Catalyst Pharma Trials - LARVOL Sigma

63 Trials

Active Trials

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Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Fycompa (perampanel) / Eisai, Catalyst Pharma

NCT03653741: Effects of Perampanel on Neurophysiology Test Perimeters

Completed

Perampanel 6 MG, perampanel

Weill Medical College of Cornell University, Eisai Inc.

Healthy

11/21

ChiCTR2100051885: Efficacy, safety and pharmacokinetics/pharmacodynamics of perampanel in the treatment of epileptic seizures

Recruiting

100

parempanel additive therapy

Huashan Hospital, Fudan University; Huashan Hospital, Fudan University, Research Fund for AMPA Mechanism and Antiepileptic Drug Research

epilepsy

NCT04118829: Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

Recruiting

Perampanel

Carilion Clinic

Epilepsy, Seizures

09/22

03/23

ChiCTR2000039510: A multi-center, open clinical trial to evaluate the effectiveness and safety of perampanel as an early add-on treatment for partial seizure

Recruiting

300

Perampanel tablets

Xuanwu Hospital of Capital Medical University; China Association Against Epilepsy, CAAE, Eisai (China) Pharmaceutical Co., Ltd.

Epilepsy

NCT04650204: Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

Terminated

Anticonvulsant Agent, Anti-seizure agent, anticonvulsant, Anticonvulsant Agents, Anticonvulsants, antiepileptic, Antiepileptic Agent, Antiepileptics, Perampanel, E2007, Fycompa, Quality-of-Life Assessment, Quality of Life Assessment, Questionnaire Administration

Mayo Clinic, National Cancer Institute (NCI)

Intractable Epilepsy, Malignant Glioma, Seizure Disorder, WHO Grade 2 Glioma, WHO Grade 3 Glioma

04/23

ChiCTR2300074575: A single-center，observational cohort study to evaluate the effectiveness and safety of perampanel monotherapy in adults with focal seizures

Completed

None

Nanjing Brain Hospital; Nanjing Brain Hospital, None

epilepsy

NCT04417907: Perampanel Titration and Cognitive Effects

Terminated

Perampanel 1 week titration, Fycompa, Perampanel 2 week titration, Perampanel 4mg, Placebo

Kimford Jay Meador, Eisai Inc.

Epilepsy

05/23

NCT05201703: Fycompa in Catamenial Epilepsy

Terminated

Fycompa, Perampanel, Fycompa with a boost

University of Florida, Eisai Inc.

Catamenial Epilepsy

12/23

ChiCTR2200055423: A clinical trial study on the effect of perampanel on the prognosis of patients with traumatic brain injury

Recruiting

200

Placebo ;Perampanel treatment

The 904th Hospital of PLA; The 904th Hospital of PLA, Municipal Health Commission of Wuxi

Traumatic brain injury

ChiCTR2200066392: A Real World Multicenter Study of Perampanel Monotherapy in Children with Epilepsy

Not yet recruiting

420

PER monotherapy

Guangzhou Women and Children's Medical Center; Guangdong Provincial People's Hospital, Nil

epilepsy

ChiCTR2300068059: To evaluate the efficacy and safety of perampanel monotherapy in the treatment of newly diagnosed children with focal epilepsy in China in a real-world setting

Recruiting

210

Pirentanil, once a day

Peking University First Hospital; Peking University First Hospital, Eisai (China) Pharmaceutical Co., Ltd.

Focal epilepsy

NCT05533814: A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures

Completed

125

RoW

Perampanel, Fycompa, E2007

Eisai Korea Inc.

Epilepsy

01/25

ChiCTR2300076947: A single-center, prospective, observational real-world study of Perampanel treatment in children aged 4-18 years with epilepsy

Recruiting

100

Department of Pediatrics, the First Affiliated Hospital of Fujian Medical University; Department of Pediatrics, the First Affiliated Hospital of Fujian Medical University, None

Epilepsy

NCT05684978: Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus

Not yet recruiting

Perampanel, Fycompa

Wayne State University

Refractory Status Epilepticus

12/27

01/28

2019-000882-19: Efficacy of add-on PEramPanel in focal motor Status epilepticus Efficacité du PEramPanel (PER) dans le traitement de l'état de mal épileptique focal moteur

Not yet recruiting

332

Europe

Fycompa, Film-coated tablet, Fycompa

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), Ministère des Solidarités et de la Santé

Patients with a focal motor status epilepticus Patients présentant un état de mal épileptique focal moteur, NA NA, Diseases [C] - Nervous System Diseases [C10]

PEPSI, NCT04309721: Perampanel in Focal Status Epilepticus

Terminated

Europe

Perampanel, Experimental group, Placebo, Control group

Assistance Publique - Hôpitaux de Paris

Epilepticus; Status, Focal Motor

11/22

11/23

2021-001839-77: Efficacy and saefety of Perampanel on behaviour and quality of life in Patients with POGZ-Related Disorder Efficacia e sicurezza del Perampanel sul comportamento e la qualità di vita nei pazienti con sindrome POGZ

Not yet recruiting

Europe

Fycompa, perampanel, [042581037], [n.a.], Coated tablet

IRCCS MATERNO INFANTILE BURLO GAROFOLO, IRCCS materno infantile Burlo Garofolo

Patients with POGZ related disorder Pazienti con varianti patogenetiche/verosimilmente patogenetiche nel gene POGZ, Patients with neurodevelopmental disorder characterized by intellectual disability and/or autism and malformations in different organs of genetic origin Pazienti con disordini del neurosviluppo caratterizzato da disabilità intellettiva e/o autismo e malformazioni in vari organi di origine monogenica, Diseases [C] - Symptoms and general pathology [C23]

NCT02914314 / 2013-005391-17: Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Completed

Europe, US

perampanel, E2007

Eisai Inc.

Epilepsy

08/22

04/23

PROSPER, NCT06401707: PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Recruiting

Perampanel, Fycompa, Placebo

University of California, San Francisco

Heart Arrest, Seizures, Status Epilepticus

05/26

10/26

ACTRN12618001984280: Perampanel for the prevention of post-stroke epilepsy- efficacy and safety

Active, not recruiting

164

Alfred Health, Alfred Health

Stroke, Epilepsy

NCT04015141 / 2018-004456-38: A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

Recruiting

100

Europe, US, RoW

Perampanel Oral Suspension, E2007, Fycompa, Perampanel Tablet

Eisai Inc.

Pediatric Epileptic Syndrome, Partial-onset Seizures

04/27

12/27

NCT05786066: The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects

Recruiting

Perampanel 6 MG, Ketamine, Placebo

Yale University, American Foundation for Suicide Prevention, National Center for PTSD, VA Connecticut Healthcare System

Depressive Disorder, Major Depressive Disorder, Bipolar Disorder, Post Traumatic Stress Disorder, Suicidal Ideation

03/33

NCT04497142: Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Completed

1/2

Perampanel, E2007, Fycompa, Standard of Care, Standard treatment (typically the anti-seizure medication levetiracetam)

Dana-Farber Cancer Institute, National Cancer Institute (NCI), Eisai Inc.

Glioma, Malignant, Surgery, Seizures

05/23

NCT03367533: Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response, Pilot Trial

Completed

Ketamine, Perampanel, Placebo

Yale University, National Institute of Mental Health (NIMH)

Depressive Disorder, Major, Post Traumatic Stress Disorder, Bipolar Disorder

07/22

NCT06450223: Bioequivalence Study of Perampanel Tablets 12 mg

Completed

RoW

Perampanel 12 MG, Fycompa 12 mg film-coated tablets

Humanis Saglık Anonim Sirketi

Epilepsy

09/23

12/23

NCT06450236: Bioequivalence Study of Perampanel Tablets 10 mg

Completed

RoW

Perampanel 10 MG, Fycompa 10Mg Tablet

Humanis Saglık Anonim Sirketi

Epilepsy

11/23

02/24

NCT06969963: Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations

Completed

RoW

Lepsiramp, 0.5 Mg/mL Oral Suspension, Perampanel 0.5mg/mL, Fycompa, 0.5 Mg/mL Oral Suspension, perampanel 0.5mg/mL

Aya Mohammed Abdel Magid Abdel Hamid, Advanced Research Center (ARC), Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals

Bioequivalence Study in Healthy Subjects

07/24

NCT05915013: Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response

Recruiting

Ketamine, Perampanel, Placebo

Yale University, National Institute of Mental Health (NIMH)

Depressive Disorder, Major, Post Traumatic Stress Disorder

12/32

NCT01871233: An Extended Access Program for Perampanel

No Longer Available

N/A

Europe, Canada, RoW

Perampanel, E2007

Eisai Inc.

Partial Onset Seizures

NCT05274035: A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children

Active, not recruiting

N/A

1000

RoW

Perampanel, Fycompa

Beijing Children's Hospital

Epilepsy

11/21

07/22

ChiCTR2300074696: A real-world multicenter clinical study of perampanel as adjunctive treatment in children with epilepsy in China

Completed

N/A

None

Department of Neurology,Wuhan Children's Hospital of Tongji Medical College,Huazhong University of Science and Technology; WuHan Children's Hospital, Construction Project of Clinical Medical Research Center for Neurodevelopmental Disabilities in Children in Hubei Province(No.HST2020-19)

epilepsy

NCT04252846: A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy

Completed

N/A

191

Europe, RoW

Perampanel, Fycompa

Eisai Limited

Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures

01/23

NCT03020797: A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Terminated

N/A

Perampanel, Fycompa, Placebo Oral Tablet

Stony Brook University, Eisai Inc.

Amyotrophic Lateral Sclerosis

01/23

02/23

NCT04202159: A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

Completed

N/A

187

Europe

Perampanel, E2007, Fycompa

Eisai GmbH

Seizures

03/23

NCT02307578: An Extended Access Program (EAP) for Perampanel

Available

N/A

Europe, RoW

Perampanel, E2007, Fycompa

Eisai Inc.

Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome

NCT04858841: Post-stroke Epilepsy: Primary Prophylaxis Study

Recruiting

N/A

180

RoW

Levetiracetam Oral Product, keppra, Perampanel Oral Product, fycompa, Placebo

National Cheng Kung University, Ministry of Science and Technology, Taiwan, National Cheng-Kung University Hospital

Middle Cerebral Artery Stroke

07/23

SUPER-CAT, NCT05756621: Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest

Recruiting

N/A

Europe

Ketamine, Perampanel, Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel, Levetiracetam, Valproate, Phenytoin, Lacosamide, Topiramate, Propofol, Midazolam, Thiopental

University of Milano Bicocca, Azienda Ospedaliera San Gerardo di Monza, Azienda Ospedaliero-Universitaria di Modena, Azienda Ospedaliera Universitaria Integrata Verona, Ospedale Centrale Bolzano, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Ospedaliero-Universitaria Careggi, Azienda Ospedaliero-Universitaria di Parma, Santa Chiara Hospital, Ospedale M. Bufalini Cesena, Azienda Ospedaliera Brotzu, Istituto Di Ricerche Farmacologiche Mario Negri

Status Epilepticus, Cardiac Arrest

03/25

ChiCTR2300070693: Pharmacokinetics and Bioequivalence study of perampanel oral suspension in healthy Chinese volunteers

Recruiting

N/A

Fed condition: the test formulation was given in the first period, and reference formulation was given in the second period ;Fed condition: the reference formulation was given in the first period, and test formulation was given in the second period ;Fasting condition: the test formulation was given in the first period, and reference formulation was given in the second period ;Fasting condition: the reference formulation was given in the first period, and test formulation was given in the second period

Deyang People's Hospital; Jiangxi Kerui Pharmaceutical Co., Ltd, Jiangxi Kerui Pharmaceutical Co., Ltd

Partial seizure of epilepsy

ChiCTR2200059080: A randomized, controlled, multicenter clinical study evaluating the efficacy and safety of perampanel versus levetiracetam monotherapy in newly diagnosed focal epilepsy greater than or equal to 12 years of age

Not yet recruiting

N/A

200

Oral perampanel ;Oral Levetiracetam

The Seventh Affiliated Hospital, Sun Yat-Sen University; The Seventh Affiliated Hospital, Sun Yat-Sen University, China Association Against Epilepsy

Epilepsy

ChiCTR2300072371: Clinical trial of perampanel in the treatment of paroxysmal kinesigenic dyskinesia

Not yet recruiting

N/A

perampanel ;oxcarbazepine

Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital, self-raised

paroxysmal kinesigenic dyskinesia

NCT06657378: A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures

Recruiting

N/A

110

Japan

No Intervention

Eisai Co., Ltd.

Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures

06/28

EPIPOP, NCT03196466: Population Pharmacokinetics of Antiepileptic in Pediatrics

Recruiting

N/A

1000

Europe

Valproic acid, carbamazepine, phenobarbital, phenytoin, levetiracetam, lamotrigine, topiramate, oxcarbazepine, stiripentol, clobazam, brivaracétam, felbamate, lacosamide, rufinamide, gabapentine, pregabaline, sultiame, tiagabine, vigabatrine, mesuximide, primidone, perampanel, ethosuximide, zonisamide, cannabidiol, genetic polymorphisms

Assistance Publique - Hôpitaux de Paris

Epilepsy

06/26

NCT05257915: A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Active, not recruiting

N/A

600

RoW

Perampanel, Fycompa

Beijing Children's Hospital

Epilepsy

10/21

06/22

NCT05497193: Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

Active, not recruiting

N/A

280

RoW

perampanel, No other interventions currently

Yang Xinwei

Focal Epilepsy

03/23

10/23

Firdapse (amifampridine) / BioMarin, Catalyst Pharma

2021-004110-20: Improving symptomatic treatment with pyridostigmine and amifampridine in patients with myasthenia gravis Verbeteren van de symptomatische behandeling met pyridostigmine en amifampridine bij patienten met myasthenia gravis.

Not yet recruiting

3/4

Europe

Amifampridine, Pyridostigmine, Tablet, Mestinon

Leiden University Medical Center, Leiden University Medical Center, NMD Pharma

Myasthenia Gravis Myasthenia Gravis, Myasthenia Gravis Myasthenia Gravis, Diseases [C] - Nervous System Diseases [C10]

2018-000358-23: Study to evaluate the efficacy and safety of amifampridine phosphate drug in patients with Congenital Myasthenic Syndromes (CMS) Studio che valuta l'efficacia e la sicurezza del farmaco amifampridina fosfato in pazienti con Sindromi Miasteniche Congenite (SMC)

Not yet recruiting

Europe

Amifampridine phoshate, Tablet, FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE

CATALYST PHARMACEUTICALS INC., Catalyst Pharmaceuticals Inc.

Congenital myasthenic syndromes Sindromi miasteniche congenite, Congenital myasthenic syndromes Sindromi miasteniche congenite, Diseases [C] - Nervous System Diseases [C10]

2018-002405-64: Clinical study evaluating the safety of amifampridine phosphate in patients with Congenital Myasthenic Syndromes (CMS) Studio clinico che valuta la sicurezza del farmaco amifampridina fosfato in pazienti con Sindromi Miasteniche Congenite (SMC)

Not yet recruiting

Europe

Amifampridina fosfato, [Amifampridina], Tablet, Firdapse

CATALYST PHARMACEUTICALS INC., CATALYST PHARMACEUTICALS INC.

Congenital Myasthenic Syndromes (CMS) Sindromi Miasteniche Congenite (SMC), Congenital Myasthenic Syndromes (CMS) Sindromi Miasteniche Congenite (SMC), Diseases [C] - Nervous System Diseases [C10]

NCT03579966 / 2017-004777-14: Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)

Terminated

Europe, US

Amifampridine Phosphate

Catalyst Pharmaceuticals, Inc.

Myasthenia Gravis, MuSK, AChR Myasthenia Gravis

08/22

IMPACT-MG, NCT05919407: Pyridostigmine and Amifampridine for Myasthenia Gravis

Recruiting

Europe

Pyridostigmine, Amifampridine (base) with modified release, Placebo

Leiden University Medical Center, NMD Pharma A/S

Myasthenia Gravis

09/24

2015-003127-62: A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia Gravis Studio randomizzato controllato con placebo per valutare l'effetto dell'amifampridina in pazienti affetti da Miastenia Grave Musk positivi

	Topline data for MuSK antibody positive myasthenia gravis
	Mar 2017 - Mar 2017: Topline data for MuSK antibody positive myasthenia gravis

Ongoing

Europe

AMIFAMPRIDINA, Tablet, FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE

FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, Catalyst Pharmaceutical Partners, Inc.

Patients with MuSK Antibody Positive Myasthenia Gravis Pazienti affetti da Miastenia Grave MuSK-positiva, Patients with MuSK Antibody Positive Myasthenia Gravis Pazienti affetti da Miastenia Grave MuSK-positiva, Diseases [C] - Musculoskeletal Diseases [C05]

2018-000160-28: Clinical study evaluating the long term safety of amifampridine phosphate in ambulatory patients with Spinal Muscular Atrophy (SMA) type 3 Studio clinico che valuta la sicurezza alungo termine del farmaco amifampridina fosfato in pazienti deambulanti con Atrofia Muscolare Spinale (SMA) tipo 3

Not yet recruiting

Europe

Amifampridina fosfato, [Amifampridina fosfato], Tablet, FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE

CATALYST PHARMACEUTICALS INC., Catalyst Pharmaceuticals, Inc.

Spinal Muscular Atrophy (SMA) Type 3 Atrofia Muscolare Spinale (SMA) tipo 3, Spinal Muscular Atrophy (SMA) Atrofia Muscolare Spinale (SMA), Diseases [C] - Nervous System Diseases [C10]

NCT05123053: Firdapse for Post-BOTOX Vocal Weakness

Recruiting

Amifampridine, Firdapse

Augusta University

Vocal Weakness(Post-BOTOX Injection)

12/23

NCT05769478: Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

Completed

Amifampridine, Firdapse

Wake Forest University Health Sciences

Botulism, Iatrogenic Botulism

10/24

EAP-001, NCT02189720: Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome

Approved for marketing

N/A

Amifampridine Phosphate, 3,4-Diaminopyridine Phosphate, 3,4 DAP, Firdapse®

Catalyst Pharmaceuticals, Inc.

Congenital Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome, Nystagmus, Acquired

Agamree (vamorolone) / Santhera

GUARDIAN, NCT06713135: A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

Recruiting

Europe, RoW

vamorolone 40 mg/mL oral suspension, vamorolone

Santhera Pharmaceuticals

Duchenne Muscular Dystrophy

09/28

2022-000844-31: Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy Studio del Vamorolone vs Placebo nel trattamento della Distrofia Muscolare di Becker

Not yet recruiting

Europe

vamorolone, [vamorolone], Oral drops, powder for suspension

ReveraGen BioPharma Inc., National Institute of health (NIH), Food and Drug administration (FDA), Foundation to Eradicate Duchenne (FED)

Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Diseases [C] - Musculoskeletal Diseases [C05]

NCT05185622 / 2025-000201-16: A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

Completed

Canada

Vamorolone, VBP15

Santhera Pharmaceuticals, Santhera Pharmaceuticals (Schweiz) AG

Duchenne Muscular Dystrophy

07/24

NCT05166109 / 2022-000844-31: A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)

Active, not recruiting

Europe, US

Vamorolone, VBP15, Placebo, Placebo to vamorolone

ReveraGen BioPharma, Inc., Santhera Pharmaceuticals

Becker Muscular Dystrophy

06/25

ChiCTR2300078541: A Randomized, Cross-over, Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Vamorolone Oral Suspension Given as A Single Dose in Healthy Chinese Adult Male Subjects

Recruiting

2mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period; 2mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period; 6mg/kg dose, first in fasted condition and then in fed condition after 4 days cleaning period; 6mg/kg dose, first in fed condition and then in fasted condition after 4 days cleaning period

Shanghai Xuhui Central Hospital; Santhera Pharmaceuticals (Switzerland) Ltd., self found

Duchenne Muscular Dystrophy

SNT-I-VAM-026, NCT06649409: Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Completed

Europe

Vamorolone, experimental drug, Eplerenone, positive control, Fludrocortisone, auxiliary medicinal product - mineralocorticoid agonist

Santhera Pharmaceuticals

Pharmacodynamic

06/24

07/24

NCT06689527: Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

Completed

Europe

Vamorolone, Test Drug, Midazolam, Reference Drug

Santhera Pharmaceuticals

Drug Interaction Potentiation

09/24

10/24

NCT03863119: Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

Approved for marketing

N/A

Vamorolone

Santhera Pharmaceuticals

Duchenne Muscular Dystrophy

NCT06564974: Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.

Recruiting

N/A

250

Vamorolone, AGAMREE®

Catalyst Pharmaceuticals, Inc.

Duchenne Muscular Dystrophy

09/30

11/30

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Fycompa (perampanel) / Eisai, Catalyst Pharma

NCT03653741: Effects of Perampanel on Neurophysiology Test Perimeters

Completed

Perampanel 6 MG, perampanel

Weill Medical College of Cornell University, Eisai Inc.

Healthy

11/21

ChiCTR2100051885: Efficacy, safety and pharmacokinetics/pharmacodynamics of perampanel in the treatment of epileptic seizures

Recruiting

100

parempanel additive therapy

Huashan Hospital, Fudan University; Huashan Hospital, Fudan University, Research Fund for AMPA Mechanism and Antiepileptic Drug Research

epilepsy

NCT04118829: Correlation of Serum Level of Perampanel (PER) Level to Cerebrospinal Fluid (CSF) Levels of PER

Recruiting

Perampanel

Carilion Clinic

Epilepsy, Seizures

09/22

03/23

ChiCTR2000039510: A multi-center, open clinical trial to evaluate the effectiveness and safety of perampanel as an early add-on treatment for partial seizure

Recruiting

300

Perampanel tablets

Xuanwu Hospital of Capital Medical University; China Association Against Epilepsy, CAAE, Eisai (China) Pharmaceutical Co., Ltd.

Epilepsy

NCT04650204: Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

Terminated

Mayo Clinic, National Cancer Institute (NCI)

Intractable Epilepsy, Malignant Glioma, Seizure Disorder, WHO Grade 2 Glioma, WHO Grade 3 Glioma

04/23

ChiCTR2300074575: A single-center，observational cohort study to evaluate the effectiveness and safety of perampanel monotherapy in adults with focal seizures

Completed

None

Nanjing Brain Hospital; Nanjing Brain Hospital, None

epilepsy

NCT04417907: Perampanel Titration and Cognitive Effects

Terminated

Perampanel 1 week titration, Fycompa, Perampanel 2 week titration, Perampanel 4mg, Placebo

Kimford Jay Meador, Eisai Inc.

Epilepsy

05/23

NCT05201703: Fycompa in Catamenial Epilepsy

Terminated

Fycompa, Perampanel, Fycompa with a boost

University of Florida, Eisai Inc.

Catamenial Epilepsy

12/23

ChiCTR2200055423: A clinical trial study on the effect of perampanel on the prognosis of patients with traumatic brain injury

Recruiting

200

Placebo ;Perampanel treatment

The 904th Hospital of PLA; The 904th Hospital of PLA, Municipal Health Commission of Wuxi

Traumatic brain injury

ChiCTR2200066392: A Real World Multicenter Study of Perampanel Monotherapy in Children with Epilepsy

Not yet recruiting

420

PER monotherapy

Guangzhou Women and Children's Medical Center; Guangdong Provincial People's Hospital, Nil

epilepsy

ChiCTR2300068059: To evaluate the efficacy and safety of perampanel monotherapy in the treatment of newly diagnosed children with focal epilepsy in China in a real-world setting

Recruiting

210

Pirentanil, once a day

Peking University First Hospital; Peking University First Hospital, Eisai (China) Pharmaceutical Co., Ltd.

Focal epilepsy

NCT05533814: A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures

Completed

125

RoW

Perampanel, Fycompa, E2007

Eisai Korea Inc.

Epilepsy

01/25

ChiCTR2300076947: A single-center, prospective, observational real-world study of Perampanel treatment in children aged 4-18 years with epilepsy

Recruiting

100

Department of Pediatrics, the First Affiliated Hospital of Fujian Medical University; Department of Pediatrics, the First Affiliated Hospital of Fujian Medical University, None

Epilepsy

NCT05684978: Efficacy and Safety of Perampanel in the Treatment of Refractory Status Epilepticus

Not yet recruiting

Perampanel, Fycompa

Wayne State University

Refractory Status Epilepticus

12/27

01/28

2019-000882-19: Efficacy of add-on PEramPanel in focal motor Status epilepticus Efficacité du PEramPanel (PER) dans le traitement de l'état de mal épileptique focal moteur

Not yet recruiting

332

Europe

Fycompa, Film-coated tablet, Fycompa

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), Ministère des Solidarités et de la Santé

Patients with a focal motor status epilepticus Patients présentant un état de mal épileptique focal moteur, NA NA, Diseases [C] - Nervous System Diseases [C10]

PEPSI, NCT04309721: Perampanel in Focal Status Epilepticus

Terminated

Europe

Perampanel, Experimental group, Placebo, Control group

Assistance Publique - Hôpitaux de Paris

Epilepticus; Status, Focal Motor

11/22

11/23

Not yet recruiting

Europe

Fycompa, perampanel, [042581037], [n.a.], Coated tablet

IRCCS MATERNO INFANTILE BURLO GAROFOLO, IRCCS materno infantile Burlo Garofolo

NCT02914314 / 2013-005391-17: Pharmacokinetic Study With an Oral Suspension of Perampanel as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Completed

Europe, US

perampanel, E2007

Eisai Inc.

Epilepsy

08/22

04/23

PROSPER, NCT06401707: PeRampanel fOr Status ePilEpticus pRophylaxis Post-cardiac Arrest

Recruiting

Perampanel, Fycompa, Placebo

University of California, San Francisco

Heart Arrest, Seizures, Status Epilepticus

05/26

10/26

ACTRN12618001984280: Perampanel for the prevention of post-stroke epilepsy- efficacy and safety

Active, not recruiting

164

Alfred Health, Alfred Health

Stroke, Epilepsy

NCT04015141 / 2018-004456-38: A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

Recruiting

100

Europe, US, RoW

Perampanel Oral Suspension, E2007, Fycompa, Perampanel Tablet

Eisai Inc.

Pediatric Epileptic Syndrome, Partial-onset Seizures

04/27

12/27

NCT05786066: The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects

Recruiting

Perampanel 6 MG, Ketamine, Placebo

Yale University, American Foundation for Suicide Prevention, National Center for PTSD, VA Connecticut Healthcare System

Depressive Disorder, Major Depressive Disorder, Bipolar Disorder, Post Traumatic Stress Disorder, Suicidal Ideation

03/33

NCT04497142: Effect of Perampanel on Peritumoral Hyperexcitability in HGG

Completed

1/2

Perampanel, E2007, Fycompa, Standard of Care, Standard treatment (typically the anti-seizure medication levetiracetam)

Dana-Farber Cancer Institute, National Cancer Institute (NCI), Eisai Inc.

Glioma, Malignant, Surgery, Seizures

05/23

NCT03367533: Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response, Pilot Trial

Completed

Ketamine, Perampanel, Placebo

Yale University, National Institute of Mental Health (NIMH)

Depressive Disorder, Major, Post Traumatic Stress Disorder, Bipolar Disorder

07/22

NCT06450223: Bioequivalence Study of Perampanel Tablets 12 mg

Completed

RoW

Perampanel 12 MG, Fycompa 12 mg film-coated tablets

Humanis Saglık Anonim Sirketi

Epilepsy

09/23

12/23

NCT06450236: Bioequivalence Study of Perampanel Tablets 10 mg

Completed

RoW

Perampanel 10 MG, Fycompa 10Mg Tablet

Humanis Saglık Anonim Sirketi

Epilepsy

11/23

02/24

NCT06969963: Bioequivalence Assessment Between Two Perampanel Oral Suspension Formulations

Completed

RoW

Lepsiramp, 0.5 Mg/mL Oral Suspension, Perampanel 0.5mg/mL, Fycompa, 0.5 Mg/mL Oral Suspension, perampanel 0.5mg/mL

Aya Mohammed Abdel Magid Abdel Hamid, Advanced Research Center (ARC), Global Napi Pharmaceuticals for Global Advanced Pharmaceuticals

Bioequivalence Study in Healthy Subjects

07/24

NCT05915013: Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response

Recruiting

Ketamine, Perampanel, Placebo

Yale University, National Institute of Mental Health (NIMH)

Depressive Disorder, Major, Post Traumatic Stress Disorder

12/32

NCT01871233: An Extended Access Program for Perampanel

No Longer Available

N/A

Europe, Canada, RoW

Perampanel, E2007

Eisai Inc.

Partial Onset Seizures

NCT05274035: A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children

Active, not recruiting

N/A

1000

RoW

Perampanel, Fycompa

Beijing Children's Hospital

Epilepsy

11/21

07/22

ChiCTR2300074696: A real-world multicenter clinical study of perampanel as adjunctive treatment in children with epilepsy in China

Completed

N/A

None

epilepsy

Completed

N/A

191

Europe, RoW

Perampanel, Fycompa

Eisai Limited

Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures

01/23

NCT03020797: A Clinical Trial to Evaluate the Safety and Efficacy of Fycompa in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Terminated

N/A

Perampanel, Fycompa, Placebo Oral Tablet

Stony Brook University, Eisai Inc.

Amyotrophic Lateral Sclerosis

01/23

02/23

NCT04202159: A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures

Completed

N/A

187

Europe

Perampanel, E2007, Fycompa

Eisai GmbH

Seizures

03/23

NCT02307578: An Extended Access Program (EAP) for Perampanel

Available

N/A

Europe, RoW

Perampanel, E2007, Fycompa

Eisai Inc.

Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome

NCT04858841: Post-stroke Epilepsy: Primary Prophylaxis Study

Recruiting

N/A

180

RoW

Levetiracetam Oral Product, keppra, Perampanel Oral Product, fycompa, Placebo

National Cheng Kung University, Ministry of Science and Technology, Taiwan, National Cheng-Kung University Hospital

Middle Cerebral Artery Stroke

07/23

SUPER-CAT, NCT05756621: Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest

Recruiting

N/A

Europe

Ketamine, Perampanel, Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel, Levetiracetam, Valproate, Phenytoin, Lacosamide, Topiramate, Propofol, Midazolam, Thiopental

Status Epilepticus, Cardiac Arrest

03/25

ChiCTR2300070693: Pharmacokinetics and Bioequivalence study of perampanel oral suspension in healthy Chinese volunteers

Recruiting

N/A

Deyang People's Hospital; Jiangxi Kerui Pharmaceutical Co., Ltd, Jiangxi Kerui Pharmaceutical Co., Ltd

Partial seizure of epilepsy

Not yet recruiting

N/A

200

Oral perampanel ;Oral Levetiracetam

The Seventh Affiliated Hospital, Sun Yat-Sen University; The Seventh Affiliated Hospital, Sun Yat-Sen University, China Association Against Epilepsy

Epilepsy

ChiCTR2300072371: Clinical trial of perampanel in the treatment of paroxysmal kinesigenic dyskinesia

Not yet recruiting

N/A

perampanel ;oxcarbazepine

Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital, self-raised

paroxysmal kinesigenic dyskinesia

NCT06657378: A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures

Recruiting

N/A

110

Japan

No Intervention

Eisai Co., Ltd.

Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures

06/28

EPIPOP, NCT03196466: Population Pharmacokinetics of Antiepileptic in Pediatrics

Recruiting

N/A

1000

Europe

Assistance Publique - Hôpitaux de Paris

Epilepsy

06/26

NCT05257915: A China RWS to Evaluate the Effectiveness and Safety of Perampanel as an add-on Treatment for Epileptic Seizure

Active, not recruiting

N/A

600

RoW

Perampanel, Fycompa

Beijing Children's Hospital

Epilepsy

10/21

06/22

NCT05497193: Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy

Active, not recruiting

N/A

280

RoW

perampanel, No other interventions currently

Yang Xinwei

Focal Epilepsy

03/23

10/23

Firdapse (amifampridine) / BioMarin, Catalyst Pharma

Not yet recruiting

3/4

Europe

Amifampridine, Pyridostigmine, Tablet, Mestinon

Leiden University Medical Center, Leiden University Medical Center, NMD Pharma

Myasthenia Gravis Myasthenia Gravis, Myasthenia Gravis Myasthenia Gravis, Diseases [C] - Nervous System Diseases [C10]

Not yet recruiting

Europe

Amifampridine phoshate, Tablet, FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE

CATALYST PHARMACEUTICALS INC., Catalyst Pharmaceuticals Inc.

Congenital myasthenic syndromes Sindromi miasteniche congenite, Congenital myasthenic syndromes Sindromi miasteniche congenite, Diseases [C] - Nervous System Diseases [C10]

Not yet recruiting

Europe

Amifampridina fosfato, [Amifampridina], Tablet, Firdapse

CATALYST PHARMACEUTICALS INC., CATALYST PHARMACEUTICALS INC.

Congenital Myasthenic Syndromes (CMS) Sindromi Miasteniche Congenite (SMC), Congenital Myasthenic Syndromes (CMS) Sindromi Miasteniche Congenite (SMC), Diseases [C] - Nervous System Diseases [C10]

NCT03579966 / 2017-004777-14: Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)

Terminated

Europe, US

Amifampridine Phosphate

Catalyst Pharmaceuticals, Inc.

Myasthenia Gravis, MuSK, AChR Myasthenia Gravis

08/22

IMPACT-MG, NCT05919407: Pyridostigmine and Amifampridine for Myasthenia Gravis

Recruiting

Europe

Pyridostigmine, Amifampridine (base) with modified release, Placebo

Leiden University Medical Center, NMD Pharma A/S

Myasthenia Gravis

09/24

	Topline data for MuSK antibody positive myasthenia gravis
	Mar 2017 - Mar 2017: Topline data for MuSK antibody positive myasthenia gravis

Ongoing

Europe

AMIFAMPRIDINA, Tablet, FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE

FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTA, Catalyst Pharmaceutical Partners, Inc.

Not yet recruiting

Europe

Amifampridina fosfato, [Amifampridina fosfato], Tablet, FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE

CATALYST PHARMACEUTICALS INC., Catalyst Pharmaceuticals, Inc.

Spinal Muscular Atrophy (SMA) Type 3 Atrofia Muscolare Spinale (SMA) tipo 3, Spinal Muscular Atrophy (SMA) Atrofia Muscolare Spinale (SMA), Diseases [C] - Nervous System Diseases [C10]

NCT05123053: Firdapse for Post-BOTOX Vocal Weakness

Recruiting

Amifampridine, Firdapse

Augusta University

Vocal Weakness(Post-BOTOX Injection)

12/23

NCT05769478: Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA

Completed

Amifampridine, Firdapse

Wake Forest University Health Sciences

Botulism, Iatrogenic Botulism

10/24

EAP-001, NCT02189720: Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS),Congenital Myasthenic Syndrome

Approved for marketing

N/A

Amifampridine Phosphate, 3,4-Diaminopyridine Phosphate, 3,4 DAP, Firdapse®

Catalyst Pharmaceuticals, Inc.

Congenital Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome, Nystagmus, Acquired

Agamree (vamorolone) / Santhera

GUARDIAN, NCT06713135: A Study on Safety and Effectiveness of Long-term Treatment With Vamorolone in Boys With Duchenne Muscular Dystrophy

Recruiting

Europe, RoW

vamorolone 40 mg/mL oral suspension, vamorolone

Santhera Pharmaceuticals

Duchenne Muscular Dystrophy

09/28

2022-000844-31: Trial of Vamorolone vs. Placebo for the Treatment of Becker Muscular Dystrophy Studio del Vamorolone vs Placebo nel trattamento della Distrofia Muscolare di Becker

Not yet recruiting

Europe

vamorolone, [vamorolone], Oral drops, powder for suspension

ReveraGen BioPharma Inc., National Institute of health (NIH), Food and Drug administration (FDA), Foundation to Eradicate Duchenne (FED)

Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Becker Muscular Dystrophy Distrofia Muscolare di Becker (BMD), Diseases [C] - Musculoskeletal Diseases [C05]

NCT05185622 / 2025-000201-16: A Study to Assess Vamorolone in Boys Ages 2 to <4 Years and 7 to <18 Years With Duchenne Muscular Dystrophy (DMD)

Completed

Canada

Vamorolone, VBP15

Santhera Pharmaceuticals, Santhera Pharmaceuticals (Schweiz) AG

Duchenne Muscular Dystrophy

07/24

NCT05166109 / 2022-000844-31: A Study to Assess Vamorolone in Becker Muscular Dystrophy (BMD)

Active, not recruiting

Europe, US

Vamorolone, VBP15, Placebo, Placebo to vamorolone

ReveraGen BioPharma, Inc., Santhera Pharmaceuticals

Becker Muscular Dystrophy

06/25

Recruiting

Shanghai Xuhui Central Hospital; Santhera Pharmaceuticals (Switzerland) Ltd., self found

Duchenne Muscular Dystrophy

SNT-I-VAM-026, NCT06649409: Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Completed

Europe

Vamorolone, experimental drug, Eplerenone, positive control, Fludrocortisone, auxiliary medicinal product - mineralocorticoid agonist

Santhera Pharmaceuticals

Pharmacodynamic

06/24

07/24

NCT06689527: Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

Completed

Europe

Vamorolone, Test Drug, Midazolam, Reference Drug

Santhera Pharmaceuticals

Drug Interaction Potentiation

09/24

10/24

NCT03863119: Expanded Access Protocol for Boys With Duchenne Muscular Dystrophy

Approved for marketing

N/A

Vamorolone

Santhera Pharmaceuticals

Duchenne Muscular Dystrophy

NCT06564974: Registry Study to Observe Long-term Safety of Vamorolone (AGAMREE®) in Patients With Duchenne Muscular Dystrophy.

Recruiting

N/A

250

Vamorolone, AGAMREE®

Catalyst Pharmaceuticals, Inc.

Duchenne Muscular Dystrophy

09/30

11/30

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