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50 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Lybalvi (olanzapine/samidorphan) / Alkermes
NCT06740890: Exercise and Olanzapine-samidorphan

Recruiting
4
30
US
Olanzapine-samidorphan + exercise
New York State Psychiatric Institute
Schizophenia Disorder, Schizoaffective Disorder, Bipolar Disorder I or II, Bipolar Disorder NOS
04/27
04/27
NCT03201757 / 2017-000918-36: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Completed
3
523
Europe, US, RoW
ALKS 3831
Alkermes, Inc.
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
09/23
09/23
QLG1130-301, NCT06649214: A Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

Not yet recruiting
3
654
NA
Olanzapine-samidorphan；, Olanzapine
Qilu Pharmaceutical Co., Ltd.
Schizophrenia
04/26
05/26
NCT05303064: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Recruiting
3
220
US, RoW
OLZ/SAM, ALKS 3831, LYBALVI, Olanzapine
Alkermes, Inc.
Schizophrenia, Bipolar I Disorder
09/26
09/26
NCT04987229: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Enrolling by invitation
3
236
US, RoW
OLZ/SAM, ALKS 3831
Alkermes, Inc.
Bipolar I Disorder, Schizophrenia
09/27
09/27
NCT05547100: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

Completed
1
12
US
LYBALVI, Olanzapine/samidorphan (OLZ/SAM), ALKS 3831
Alkermes, Inc.
Focus of Study is on Healthy Lactating Women
11/22
11/22
NCT04987658: Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

Completed
1
7
US
OLZ/SAM, ALKS 3831
Alkermes, Inc.
Bipolar I Disorder
08/23
08/23
Vumerity (diroximel fumarate) / Biogen
DELIVER-MS, NCT03535298: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

Active, not recruiting
4
800
Europe, US
Early Highly Effective Therapies Group, Lemtrada (alemtuzumab), Ocrevus (ocrelizumab), Tysabri (natalizumab), Rituxan (rituximab), Kesimpta (ofatumumab), Briumvi (ublituximab), Escalation Therapies Group, Betaseron (beta interferon), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Extavia (beta interferon), Gilenya (fingolimod), Glatopa (glatiramer acetate), Plegridy (beta interferon), Rebif (beta interferon), Tecfidera (dimethyl fumarate), Avonex (beta interferon), Mavenclad (cladribine), Mayzent (siponimod), Vumerity (diroximel fumarate), Zeposia (ozanimod), Bafiertam (monomethyl fumarate), Ponvory (ponesimod)
The Cleveland Clinic, University of Nottingham
Multiple Sclerosis, Relapsing-Remitting
07/27
09/30
NCT05083923: A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)

Completed
3
102
Japan, RoW
Diroximel fumarate, Vumerity, BIIB098, ALK8700
Biogen
Relapsing Forms of Multiple Sclerosis
09/24
09/24
STHENOS, NCT04788615 / 2020-004505-32: Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

Active, not recruiting
3
185
Europe
Ofatumumab, OMB157, First line DMT, Glatiramer acetate or Interferon or Peg-Interferon beta-1a or Teriflunomide or Dimethyl fumarate or Diroximel fumarate
Novartis Pharmaceuticals, Novartis Pharma AG
Multiple Sclerosis
11/25
02/26
NCT05798520: A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)

Recruiting
2
275
Europe, US, RoW
BIIB091, DRF, Placebo
Biogen
Relapsing Forms of Multiple Sclerosis
09/27
09/27
NCT06319339: Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

Recruiting
1
20
US
Vumerity, diroximal fumarate, Placebo
University of Nebraska
Peripheral Artery Disease, Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
08/25
08/25
NCT06385197: Improving the Effect of Multiple Sclerosis Drugs by Chronobiology

Completed
N/A
8
RoW
App randomizing dosing regimen
Hadassah Medical Organization
Multiple Sclerosis
06/23
06/23
NCT04746976: Study of Diroximel Fumarate in the Real-World Setting

Terminated
N/A
75
US
Diroximel Fumarate, VUMERITY, BIIB098
Biogen
Relapsing Forms of MS
04/23
04/23
EXPER-CA/IL, NCT04948606: Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

Terminated
N/A
64
RoW
Diroximel Fumarate, VUMERITY, BIIB098
Biogen
Relapsing Forms of MS
04/23
04/23
FORTUNE, NCT06957808: Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

Recruiting
N/A
30
Europe
Diroximel fumarate (DRF), Vumerity, Placebo
King's College London, Rosetrees Trust
Schizophrenia Disorders
03/26
06/26
TREAT-MS, NCT03500328: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

Active, not recruiting
N/A
900
US
Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq, Tysabri, Lemtrada, Ocrevus, Rituxan/Riabni/Truxima/Ruxience, Mavenclad, Kesimpta, Briumvi, Ocrevus Zunovo, Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod, Copaxone, Glatopa, Avonex, Betaseron, Extavia, Rebif, Plegridy, Aubagio, Tecfidera, Vumerity, Bafiertam, Gilenya, Mayzent, Zeposia, Ponvory, Tascenso
Johns Hopkins University, Patient-Centered Outcomes Research Institute, National Multiple Sclerosis Society
Multiple Sclerosis, Relapsing-Remitting
08/26
08/26
STATURE, NCT04676204: Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation
N/A
323
RoW
Cladribine, Mavenclad, Dimethyl fumarate, Tecfidera, Fingolimod, Gilenya, Teriflunomide, Aubagio, Ozanimod, Zeposia, Diroximel fumarate, Vumerity
Monash University
Multiple Sclerosis, Adherence, Medication
11/25
07/26
NCT05688436: A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Recruiting
N/A
1178
US
Diroximel Fumarate, VUMERITY, BIIB098, Alemtuzumab, Fingolimod, Glatiramer acetate, Interferon beta, Natalizumab, Tysabri, BG00002, Ocrelizumab, Ofatumumab, Ozanimod, Peginterferon beta-1a, Ponesimod, Siponimod
Biogen
Multiple Sclerosis
01/31
01/31
NCT05658497: Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Recruiting
N/A
908
Europe, US
Diroximel Fumarate, VUMERITY, BIIB098, Avonex, BG9418, interferon beta-1a, Tysabri, Natalizumab, BG00002, Dimethyl Fumarate, Tecfidera, DMF, BG00012
Biogen
Multiple Sclerosis
07/32
07/32
NCT05767736: A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Active, not recruiting
N/A
10500
US
Diroximel Fumarate, VUMERITY, BIIB098, Dimethyl Fumarate, Tecfidera, DMF, BG00012, Disease-Modifying Therapies (DMTs)
Biogen
Multiple Sclerosis
12/32
12/32
nemvaleukin alfa (ALKS 4230) / Mural Oncology
ARTISTRY-7, NCT05092360 / 2021-002326-24: Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer

Active, not recruiting
3
456
Europe, Canada, US, RoW
Nemvaleukin and Pembrolizumab Combination, Nemvaleukin alfa, ALKS 4230, Keytruda, Pembrolizumab, Nemvaleukin, Pegylated Liposomal Doxorubicin (PLD), PLD- CAELYX, DOXIL, LIPODOX, Myocet, Paclitaxel, Nov-Onxol, Taxol, Onxol, Paclitaxel Novaplus, Topotecan, Hycamtin, Potactasol, Gemcitabine, Gemzar, Infugem
Mural Oncology, Inc, Merck Sharp & Dohme LLC
Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
05/26
05/27
2021-001557-31: A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6 Un estudio de fase II, abierto, multicéntrico y con cohortes sobre la monoterapia con nemvaleukin alfa (ALKS 4230) administrado por vía subcutánea en pacientes con melanoma cutáneo avanzado o por vía intravenosa en pacientes con melanoma mucoso avanzado que han recibido previamente un tratamiento anti-PD(L)1: ARTISTRY-6

Not yet recruiting
2
110
Europe
Nemvaleukin Alfa (Formulation 2), ALKS 4230; RDB-1450, Lyophilisate and solvent for solution for injection
Alkermes, Inc., ALKERMES, Alkermes, Inc.
Advanced cutaneous melanoma and Advanced mucosal melanoma Melanoma cutáneo avanzado y melanoma mucoso avanzado, Cancer Cáncer, Diseases [C] - Cancer [C04]
 
 
ARTISTRY-6, NCT04830124 / 2021-001557-31: Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma -

Checkmark MHRA granted Innovation Passport Designation for the treatment of mucosal melanoma
Jan 2023 - Jan 2023: MHRA granted Innovation Passport Designation for the treatment of mucosal melanoma
Terminated
2
173
Europe, Canada, US, RoW
Nemvaleukin Alfa Subcutaneous, ALKS 4230 Subcutaneous, Nemvaleukin Alfa Intravenous, ALKS 4230 Intravenous, Nemvaleukin Alfa Intravenous Less Frequent Dosing, Pembrolizumab, Keytruda
Mural Oncology, Inc, Alkermes, Inc.
Cutaneous Melanoma, Mucosal Melanoma
05/25
05/25
ARTISTRY-2, NCT03861793 / 2019-002013-20: A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors

Checkmark Data from ARTISTRY-2 trial in combination with Keytruda for solid tumor at ASCO 2021
Jun 2021 - Jun 2021: Data from ARTISTRY-2 trial in combination with Keytruda for solid tumor at ASCO 2021
Completed
1/2
116
Europe, Canada, US, RoW
ALKS 4230, Pembrolizumab, Keytruda
Mural Oncology, Inc
Advanced Solid Tumors
03/23
03/23
2022-003662-21: Study of Nemvaleukin Alfa Given Once or Twice in a Cycle as Monotherapy and in Combination with Pembrolizumab and its Impact on Tumors in Patients with Solid Tumors Estudio de Nemvaleucina Alfa administrado una o dos veces en un ciclo como monoterapia y en combinación con pembrolizumab y su impacto en tumores en pacientes con tumores sólidos.

Not yet recruiting
1/2
105
Europe
Nemvaleukin Alfa, ALKS 4230; RDB-1450, Lyophilisate for solution for infusion, Concentrate for solution for infusion, KEYTRUDA 25 mg/mL concentrate for solution for infusion
Alkermes, Inc., Alkermes, Inc.
Patients with advanced solid malignancies Pacientes con tumores sólidos malignos avanzados, Cutaneous melanoma, Renal cell carcinoma, Triple-negative breast cancer, Microsatellite stable colorectal cancer, Microsatellite instable-high solid tumors, or ovarian cancer. Melanoma cutáneo, carcinoma de células renales, cáncer de mama triple negativo, cáncer colorrectal estable por microsatélite, tumores sólidos inestables por microsatélite o cáncer de ovario., Diseases [C] - Cancer [C04]
 
 
ARTISTRY-1, NCT02799095 / 2019-001998-90: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

Completed
1/2
243
Europe, Canada, US, RoW
ALKS 4230, ALKS 4230 + pembrolizumab
Mural Oncology, Inc
Advanced Solid Tumors
03/23
08/23
ARTISTRY-3, NCT04592653 / 2022-003662-21: Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab

Active, not recruiting
1/2
78
Europe, US
Nemvaleukin alfa, ALKS 4230, Pembrolizumab, Keytruda
Mural Oncology, Inc, Alkermes, Inc.
Advanced Solid Tumor
07/24
12/24
Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
2017-004706-18: Long acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery

Not yet recruiting
4
150
Europe
Vivitrol (Extended-release naltrexone hydrochloride for extended-release injectable suspension), N07BB04, Injection, Vivitrol
Akershus University Hospital, Norwegian Research Council, Akershus University Hospital, Haukeland University Hospital, Sørlandet Hospital Trust, Vestfold Hospital Trust, Oslo University Hospital Trust
Opioid addiction, Addiction to heroin and other opioids, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
IM-NTX, NCT05087771: In Hospital IM Naltrexone: A Pilot Study

Withdrawn
4
90
NA
injectable naltrexone, Vivitrol, oral naltrexone
University of Colorado, Denver
Alcohol Use Disorder
12/22
06/23
NCT04219540: Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

Completed
4
675
US
XR-B (SUBLOCADETM), SUBLOCADE TM, XR-NTX, Vivitrol®
NYU Langone Health, National Institute on Drug Abuse (NIDA)
Opioid-use Disorder
08/24
02/25
NCT05028062: Naltrexone in AUD Reward Drinkers

Recruiting
4
60
US
XR-NTX 380 mg, intramuscular injection, Vivitrol naltrexone for extended-release injectable suspension, Medical Management, Placebo intramuscular injection, Inactive placebo
University of Pennsylvania, Alkermes, Inc.
Alcohol Use Disorder, Alcoholism
07/26
12/27
NCT06233799: Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

Recruiting
3
360
US
extended-release naltrexone (XR-NTX), Vivitrol, extended release bupropion (BUP-XL) tablets (BUP-XL), Wellbutrin, iPLB, Placebo injections, oPLB, Placebo tablets
National Institute on Drug Abuse (NIDA)
Methamphetamine-dependence, Methamphetamine Abuse
10/26
04/27
NCT05458609: Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

Completed
3
8
US
Lemborexant 10 mg, Dayvigo, Naltrexone, Vivitrol, Revia
Baylor College of Medicine
Alcohol Use Disorder
01/24
01/24
MATPharm, NCT04139213: Medication Maintenance Therapy in Community Pharmacy Settings

Active, not recruiting
2/3
250
US
buprenorphine/naloxone oral product, Suboxone, injectable naltrexone, Vivitrol, Pharmacy maintenance addiction care, oral naltrexone
Lifespan, University of Rhode Island, The Miriam Hospital
Opioid-use Disorder
09/22
10/22
2016-004710-95: Extended-release injectable suspension naltrexone (XR-NTX) as an adjunct pharmacotherapy for prevention of drug use in patients with substance use disorder in treatment for ADHD

Not yet recruiting
2
128
Europe
Naltrexone, Injection, vivitrol
Beroendecentrum Stockholm, Beroendecentrum Stockholm, Alkermes, Swedish research council, Swedish research council for health, working life and welfare
Amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity Disorder), Patients who fulfil DSMIV/5 criteria for amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity Disorder), respectively, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT03852628: Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD

Terminated
2
69
US
2mg Buprenex and 380mg Vivitrol, 2mg Buprenex (SL, qd) and 380mg Vivitrol (IM, q4weeks), 2mg BUP/NLTRX, Placebo (SL pill qd, IM injection q4weeks), Placebo
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, United States Department of Defense, RTI International
Post Traumatic Stress Disorder, Alcohol Abuse
05/22
01/23
AMOHI-1, NCT04480554: Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

Recruiting
2
225
US, RoW
Methadone, Buprenorphine/naloxone, Suboxone, XR-Naltrexone, Vivitrol
University of Pennsylvania, National Institute of Drug Abuse, The Wistar Institute, Institute of Applied Medicine and Epidemiology (IMEA), Ho Chi Minh City CDC
Opioid-use Disorder, HIV-1-infection, Immune Activation, Inflammation, Methadone, Buprenorphine, Naltrexone, Antiretroviral Treatment
06/25
06/25
NCT04454411: Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

Not yet recruiting
2
200
NA
Brixadi, Buprenorphine Injectable Product, Vivitrol, Naltrexone Injectable Product
University of Pennsylvania
Opioid Dependence
01/26
01/27
NCT04464980: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Active, not recruiting
2
2190
US
SL-BUP, sublingual buprenorphine, Suboxone, XR-BUP, extended-release buprenorphine, CAM2038, Brixadi, XR-NTX, extended-release naltrexone, Vivitrol, MM, MMR, MMD
NYU Langone Health, New York State Psychiatric Institute, Columbia University, Harvard Medical School (HMS and HSDM), Mclean Hospital, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
Opioid Use Disorder (OUD)
12/26
12/26
NCT05596955: Open Label Comparison of Injectable Buprenorphine ( Brixadi®) and Naltrexone (Vivitrol®) for Opioid Use Disorder

Terminated
2
3
US
Buprenorphine injection, Buprenorphine, Naltrexone Injection, Naltrexone
University of Pennsylvania
Opioid Use Disorder
08/24
08/24
NCT05304364: Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)

Completed
1
10
RoW
Combination Product: Naltrexone, DLP-160
Delpor, Inc.
Opiod Use Disorder
10/22
11/22
NCT04828694: Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections

Completed
1
24
US
BICX104, Vivitrol
BioCorRx Inc, National Institute on Drug Abuse (NIDA), The HEAL Initiative (https://heal.nih.gov/)
Opioid-use Disorder
02/23
03/23
NCT05620940: A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.

Recruiting
1
40
RoW
Vivitrol Injectable Product, IVL3004, IVL4002
Inventage Lab., Inc.
Opioid Dependence, Alcohol Dependence
05/25
05/25
HSC-MS-24-0024, NCT06374290: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

Recruiting
1
20
US
Naltrexone (Vivitrol), Bupropion
The University of Texas Health Science Center, Houston
Smoking Cessation
01/26
01/26
NCT03976258: Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

Completed
N/A
190
US
buprenorphine/naloxone, Methadone, Naltrexone Injection, Vivitrol, Heroin
MetroHealth Medical Center, National Institute on Drug Abuse (NIDA)
HIV Infection, Opioid-use Disorder, Cardiovascular Diseases
12/22
12/22
ALKS 2680 / Alkermes
ALKS 2680-301, NCT06767683: A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Recruiting
2/3
256
Europe, US, RoW
ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg, ALKS 2680, 18mg
Alkermes, Inc.
Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
06/28
06/28
Vibrance-1, NCT06358950: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

Active, not recruiting
2
80
Europe, US, RoW
ALKS 2680, Placebo
Alkermes, Inc.
Narcolepsy Type 1
07/25
07/25
Vibrance-2, NCT06555783: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Recruiting
2
80
Europe, US, RoW
ALKS 2680, Placebo
Alkermes, Inc.
Narcolepsy Type 2
08/25
09/25
Vibrance-3, NCT06843590: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Recruiting
2
96
US
ALKS 2680, Placebo
Alkermes, Inc.
Idiopathic Hypersomnia
06/26
06/26
HDAC inhibitor / Alkermes
No trials found
MURA-7012 / Mural Oncology
No trials found
MURA-8518 / Mural Oncology
No trials found
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Lybalvi (olanzapine/samidorphan) / Alkermes
NCT06740890: Exercise and Olanzapine-samidorphan

Recruiting
4
30
US
Olanzapine-samidorphan + exercise
New York State Psychiatric Institute
Schizophenia Disorder, Schizoaffective Disorder, Bipolar Disorder I or II, Bipolar Disorder NOS
04/27
04/27
NCT03201757 / 2017-000918-36: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Completed
3
523
Europe, US, RoW
ALKS 3831
Alkermes, Inc.
Schizophrenia, Schizophreniform Disorder, Bipolar I Disorder
09/23
09/23
QLG1130-301, NCT06649214: A Phase III Clinical Study to Evaluate the Safety and Efficacy of Olanzapine-Samidorphan Tablets in Adults With Schizophrenia

Not yet recruiting
3
654
NA
Olanzapine-samidorphan；, Olanzapine
Qilu Pharmaceutical Co., Ltd.
Schizophrenia
04/26
05/26
NCT05303064: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder

Recruiting
3
220
US, RoW
OLZ/SAM, ALKS 3831, LYBALVI, Olanzapine
Alkermes, Inc.
Schizophrenia, Bipolar I Disorder
09/26
09/26
NCT04987229: Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects

Enrolling by invitation
3
236
US, RoW
OLZ/SAM, ALKS 3831
Alkermes, Inc.
Bipolar I Disorder, Schizophrenia
09/27
09/27
NCT05547100: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan

Completed
1
12
US
LYBALVI, Olanzapine/samidorphan (OLZ/SAM), ALKS 3831
Alkermes, Inc.
Focus of Study is on Healthy Lactating Women
11/22
11/22
NCT04987658: Phase 1 Study of OLZ/SAM in Pediatric Subjects With Bipolar I Disorder

Completed
1
7
US
OLZ/SAM, ALKS 3831
Alkermes, Inc.
Bipolar I Disorder
08/23
08/23
Vumerity (diroximel fumarate) / Biogen
DELIVER-MS, NCT03535298: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS

Active, not recruiting
4
800
Europe, US
Early Highly Effective Therapies Group, Lemtrada (alemtuzumab), Ocrevus (ocrelizumab), Tysabri (natalizumab), Rituxan (rituximab), Kesimpta (ofatumumab), Briumvi (ublituximab), Escalation Therapies Group, Betaseron (beta interferon), Copaxone (glatiramer acetate), Aubagio (teriflunomide), Extavia (beta interferon), Gilenya (fingolimod), Glatopa (glatiramer acetate), Plegridy (beta interferon), Rebif (beta interferon), Tecfidera (dimethyl fumarate), Avonex (beta interferon), Mavenclad (cladribine), Mayzent (siponimod), Vumerity (diroximel fumarate), Zeposia (ozanimod), Bafiertam (monomethyl fumarate), Ponvory (ponesimod)
The Cleveland Clinic, University of Nottingham
Multiple Sclerosis, Relapsing-Remitting
07/27
09/30
NCT05083923: A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)

Completed
3
102
Japan, RoW
Diroximel fumarate, Vumerity, BIIB098, ALK8700
Biogen
Relapsing Forms of Multiple Sclerosis
09/24
09/24
STHENOS, NCT04788615 / 2020-004505-32: Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS

Active, not recruiting
3
185
Europe
Ofatumumab, OMB157, First line DMT, Glatiramer acetate or Interferon or Peg-Interferon beta-1a or Teriflunomide or Dimethyl fumarate or Diroximel fumarate
Novartis Pharmaceuticals, Novartis Pharma AG
Multiple Sclerosis
11/25
02/26
NCT05798520: A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)

Recruiting
2
275
Europe, US, RoW
BIIB091, DRF, Placebo
Biogen
Relapsing Forms of Multiple Sclerosis
09/27
09/27
NCT06319339: Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease

Recruiting
1
20
US
Vumerity, diroximal fumarate, Placebo
University of Nebraska
Peripheral Artery Disease, Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Arterial Occlusive Disease
08/25
08/25
NCT06385197: Improving the Effect of Multiple Sclerosis Drugs by Chronobiology

Completed
N/A
8
RoW
App randomizing dosing regimen
Hadassah Medical Organization
Multiple Sclerosis
06/23
06/23
NCT04746976: Study of Diroximel Fumarate in the Real-World Setting

Terminated
N/A
75
US
Diroximel Fumarate, VUMERITY, BIIB098
Biogen
Relapsing Forms of MS
04/23
04/23
EXPER-CA/IL, NCT04948606: Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

Terminated
N/A
64
RoW
Diroximel Fumarate, VUMERITY, BIIB098
Biogen
Relapsing Forms of MS
04/23
04/23
FORTUNE, NCT06957808: Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia

Recruiting
N/A
30
Europe
Diroximel fumarate (DRF), Vumerity, Placebo
King's College London, Rosetrees Trust
Schizophrenia Disorders
03/26
06/26
TREAT-MS, NCT03500328: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial

Active, not recruiting
N/A
900
US
Natalizumab/natalizumab-sztn, Alemtuzumab, Ocrelizumab, Rituximab/rituximab-arrx/rituximab-abbs/rituximab-pvvr, Cladribine, Ofatumumab, Ublituximab-xiiy, Ocrelizumab and hyaluronidase-ocsq, Tysabri, Lemtrada, Ocrevus, Rituxan/Riabni/Truxima/Ruxience, Mavenclad, Kesimpta, Briumvi, Ocrevus Zunovo, Glatiramer acetate, Interferons (intramuscular, subcutaneous, pegylated) Teriflunomide, Fumarates (dimethyl, diroximel, monomethyl) Fingolimod, Siponimod, Ozanimod, Ponesimod, Copaxone, Glatopa, Avonex, Betaseron, Extavia, Rebif, Plegridy, Aubagio, Tecfidera, Vumerity, Bafiertam, Gilenya, Mayzent, Zeposia, Ponvory, Tascenso
Johns Hopkins University, Patient-Centered Outcomes Research Institute, National Multiple Sclerosis Society
Multiple Sclerosis, Relapsing-Remitting
08/26
08/26
STATURE, NCT04676204: Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation
N/A
323
RoW
Cladribine, Mavenclad, Dimethyl fumarate, Tecfidera, Fingolimod, Gilenya, Teriflunomide, Aubagio, Ozanimod, Zeposia, Diroximel fumarate, Vumerity
Monash University
Multiple Sclerosis, Adherence, Medication
11/25
07/26
NCT05688436: A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Recruiting
N/A
1178
US
Diroximel Fumarate, VUMERITY, BIIB098, Alemtuzumab, Fingolimod, Glatiramer acetate, Interferon beta, Natalizumab, Tysabri, BG00002, Ocrelizumab, Ofatumumab, Ozanimod, Peginterferon beta-1a, Ponesimod, Siponimod
Biogen
Multiple Sclerosis
01/31
01/31
NCT05658497: Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)

Recruiting
N/A
908
Europe, US
Diroximel Fumarate, VUMERITY, BIIB098, Avonex, BG9418, interferon beta-1a, Tysabri, Natalizumab, BG00002, Dimethyl Fumarate, Tecfidera, DMF, BG00012
Biogen
Multiple Sclerosis
07/32
07/32
NCT05767736: A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Active, not recruiting
N/A
10500
US
Diroximel Fumarate, VUMERITY, BIIB098, Dimethyl Fumarate, Tecfidera, DMF, BG00012, Disease-Modifying Therapies (DMTs)
Biogen
Multiple Sclerosis
12/32
12/32
nemvaleukin alfa (ALKS 4230) / Mural Oncology
ARTISTRY-7, NCT05092360 / 2021-002326-24: Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab in Patients With Platinum-Resistant Epithelial Ovarian Cancer

Active, not recruiting
3
456
Europe, Canada, US, RoW
Nemvaleukin and Pembrolizumab Combination, Nemvaleukin alfa, ALKS 4230, Keytruda, Pembrolizumab, Nemvaleukin, Pegylated Liposomal Doxorubicin (PLD), PLD- CAELYX, DOXIL, LIPODOX, Myocet, Paclitaxel, Nov-Onxol, Taxol, Onxol, Paclitaxel Novaplus, Topotecan, Hycamtin, Potactasol, Gemcitabine, Gemzar, Infugem
Mural Oncology, Inc, Merck Sharp & Dohme LLC
Platinum-resistant Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
05/26
05/27
2021-001557-31: A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]1 Therapy - ARTISTRY-6 Un estudio de fase II, abierto, multicéntrico y con cohortes sobre la monoterapia con nemvaleukin alfa (ALKS 4230) administrado por vía subcutánea en pacientes con melanoma cutáneo avanzado o por vía intravenosa en pacientes con melanoma mucoso avanzado que han recibido previamente un tratamiento anti-PD(L)1: ARTISTRY-6

Not yet recruiting
2
110
Europe
Nemvaleukin Alfa (Formulation 2), ALKS 4230; RDB-1450, Lyophilisate and solvent for solution for injection
Alkermes, Inc., ALKERMES, Alkermes, Inc.
Advanced cutaneous melanoma and Advanced mucosal melanoma Melanoma cutáneo avanzado y melanoma mucoso avanzado, Cancer Cáncer, Diseases [C] - Cancer [C04]
 
 
ARTISTRY-6, NCT04830124 / 2021-001557-31: Nemvaleukin Alfa Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Cutaneous or Mucosal Melanoma -

Checkmark MHRA granted Innovation Passport Designation for the treatment of mucosal melanoma
Jan 2023 - Jan 2023: MHRA granted Innovation Passport Designation for the treatment of mucosal melanoma
Terminated
2
173
Europe, Canada, US, RoW
Nemvaleukin Alfa Subcutaneous, ALKS 4230 Subcutaneous, Nemvaleukin Alfa Intravenous, ALKS 4230 Intravenous, Nemvaleukin Alfa Intravenous Less Frequent Dosing, Pembrolizumab, Keytruda
Mural Oncology, Inc, Alkermes, Inc.
Cutaneous Melanoma, Mucosal Melanoma
05/25
05/25
ARTISTRY-2, NCT03861793 / 2019-002013-20: A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine ALKS 4230 (Nemvaleukin Alfa) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Subjects With Select Advanced or Metastatic Solid Tumors

Checkmark Data from ARTISTRY-2 trial in combination with Keytruda for solid tumor at ASCO 2021
Jun 2021 - Jun 2021: Data from ARTISTRY-2 trial in combination with Keytruda for solid tumor at ASCO 2021
Completed
1/2
116
Europe, Canada, US, RoW
ALKS 4230, Pembrolizumab, Keytruda
Mural Oncology, Inc
Advanced Solid Tumors
03/23
03/23
2022-003662-21: Study of Nemvaleukin Alfa Given Once or Twice in a Cycle as Monotherapy and in Combination with Pembrolizumab and its Impact on Tumors in Patients with Solid Tumors Estudio de Nemvaleucina Alfa administrado una o dos veces en un ciclo como monoterapia y en combinación con pembrolizumab y su impacto en tumores en pacientes con tumores sólidos.

Not yet recruiting
1/2
105
Europe
Nemvaleukin Alfa, ALKS 4230; RDB-1450, Lyophilisate for solution for infusion, Concentrate for solution for infusion, KEYTRUDA 25 mg/mL concentrate for solution for infusion
Alkermes, Inc., Alkermes, Inc.
Patients with advanced solid malignancies Pacientes con tumores sólidos malignos avanzados, Cutaneous melanoma, Renal cell carcinoma, Triple-negative breast cancer, Microsatellite stable colorectal cancer, Microsatellite instable-high solid tumors, or ovarian cancer. Melanoma cutáneo, carcinoma de células renales, cáncer de mama triple negativo, cáncer colorrectal estable por microsatélite, tumores sólidos inestables por microsatélite o cáncer de ovario., Diseases [C] - Cancer [C04]
 
 
ARTISTRY-1, NCT02799095 / 2019-001998-90: A Study of the Effects of ALKS 4230 (Nemvaleukin Alfa) on Subjects With Solid Tumors

Completed
1/2
243
Europe, Canada, US, RoW
ALKS 4230, ALKS 4230 + pembrolizumab
Mural Oncology, Inc
Advanced Solid Tumors
03/23
08/23
ARTISTRY-3, NCT04592653 / 2022-003662-21: Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab

Active, not recruiting
1/2
78
Europe, US
Nemvaleukin alfa, ALKS 4230, Pembrolizumab, Keytruda
Mural Oncology, Inc, Alkermes, Inc.
Advanced Solid Tumor
07/24
12/24
Vivitrol (naltrexone extended-release injectable suspension) / Alkermes
2017-004706-18: Long acting naltrexone for opioid addiction: the importance of mental, physical and societal factors for sustained abstinence and recovery

Not yet recruiting
4
150
Europe
Vivitrol (Extended-release naltrexone hydrochloride for extended-release injectable suspension), N07BB04, Injection, Vivitrol
Akershus University Hospital, Norwegian Research Council, Akershus University Hospital, Haukeland University Hospital, Sørlandet Hospital Trust, Vestfold Hospital Trust, Oslo University Hospital Trust
Opioid addiction, Addiction to heroin and other opioids, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
IM-NTX, NCT05087771: In Hospital IM Naltrexone: A Pilot Study

Withdrawn
4
90
NA
injectable naltrexone, Vivitrol, oral naltrexone
University of Colorado, Denver
Alcohol Use Disorder
12/22
06/23
NCT04219540: Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults

Completed
4
675
US
XR-B (SUBLOCADETM), SUBLOCADE TM, XR-NTX, Vivitrol®
NYU Langone Health, National Institute on Drug Abuse (NIDA)
Opioid-use Disorder
08/24
02/25
NCT05028062: Naltrexone in AUD Reward Drinkers

Recruiting
4
60
US
XR-NTX 380 mg, intramuscular injection, Vivitrol naltrexone for extended-release injectable suspension, Medical Management, Placebo intramuscular injection, Inactive placebo
University of Pennsylvania, Alkermes, Inc.
Alcohol Use Disorder, Alcoholism
07/26
12/27
NCT06233799: Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder

Recruiting
3
360
US
extended-release naltrexone (XR-NTX), Vivitrol, extended release bupropion (BUP-XL) tablets (BUP-XL), Wellbutrin, iPLB, Placebo injections, oPLB, Placebo tablets
National Institute on Drug Abuse (NIDA)
Methamphetamine-dependence, Methamphetamine Abuse
10/26
04/27
NCT05458609: Lemborexant Augmentation of Naltrexone for Alcohol Craving and Sleep

Completed
3
8
US
Lemborexant 10 mg, Dayvigo, Naltrexone, Vivitrol, Revia
Baylor College of Medicine
Alcohol Use Disorder
01/24
01/24
MATPharm, NCT04139213: Medication Maintenance Therapy in Community Pharmacy Settings

Active, not recruiting
2/3
250
US
buprenorphine/naloxone oral product, Suboxone, injectable naltrexone, Vivitrol, Pharmacy maintenance addiction care, oral naltrexone
Lifespan, University of Rhode Island, The Miriam Hospital
Opioid-use Disorder
09/22
10/22
2016-004710-95: Extended-release injectable suspension naltrexone (XR-NTX) as an adjunct pharmacotherapy for prevention of drug use in patients with substance use disorder in treatment for ADHD

Not yet recruiting
2
128
Europe
Naltrexone, Injection, vivitrol
Beroendecentrum Stockholm, Beroendecentrum Stockholm, Alkermes, Swedish research council, Swedish research council for health, working life and welfare
Amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity Disorder), Patients who fulfil DSMIV/5 criteria for amphetamine dependence and ADHD (Attention-Deficit/Hyperactivity Disorder), respectively, Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT03852628: Kappa Opioid Receptor Antagonism for the Tx of AUD and Comorbid PTSD

Terminated
2
69
US
2mg Buprenex and 380mg Vivitrol, 2mg Buprenex (SL, qd) and 380mg Vivitrol (IM, q4weeks), 2mg BUP/NLTRX, Placebo (SL pill qd, IM injection q4weeks), Placebo
Pharmacotherapies for Alcohol and Substance Use Disorders Alliance, United States Department of Defense, RTI International
Post Traumatic Stress Disorder, Alcohol Abuse
05/22
01/23
AMOHI-1, NCT04480554: Anti-retroviral Therapy, Medications for Opioid Use Disorder, Opioids and HIV Infection - Study 1

Recruiting
2
225
US, RoW
Methadone, Buprenorphine/naloxone, Suboxone, XR-Naltrexone, Vivitrol
University of Pennsylvania, National Institute of Drug Abuse, The Wistar Institute, Institute of Applied Medicine and Epidemiology (IMEA), Ho Chi Minh City CDC
Opioid-use Disorder, HIV-1-infection, Immune Activation, Inflammation, Methadone, Buprenorphine, Naltrexone, Antiretroviral Treatment
06/25
06/25
NCT04454411: Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

Not yet recruiting
2
200
NA
Brixadi, Buprenorphine Injectable Product, Vivitrol, Naltrexone Injectable Product
University of Pennsylvania
Opioid Dependence
01/26
01/27
NCT04464980: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Active, not recruiting
2
2190
US
SL-BUP, sublingual buprenorphine, Suboxone, XR-BUP, extended-release buprenorphine, CAM2038, Brixadi, XR-NTX, extended-release naltrexone, Vivitrol, MM, MMR, MMD
NYU Langone Health, New York State Psychiatric Institute, Columbia University, Harvard Medical School (HMS and HSDM), Mclean Hospital, National Institute on Drug Abuse (NIDA), The Emmes Company, LLC
Opioid Use Disorder (OUD)
12/26
12/26
NCT05596955: Open Label Comparison of Injectable Buprenorphine ( Brixadi®) and Naltrexone (Vivitrol®) for Opioid Use Disorder

Terminated
2
3
US
Buprenorphine injection, Buprenorphine, Naltrexone Injection, Naltrexone
University of Pennsylvania
Opioid Use Disorder
08/24
08/24
NCT05304364: Safety, Tolerability, and Pharmacokinetics of Naltrexone Implant (DLP-160)

Completed
1
10
RoW
Combination Product: Naltrexone, DLP-160
Delpor, Inc.
Opiod Use Disorder
10/22
11/22
NCT04828694: Pharmacokinetic and Safety Study of Naltrexone Release From Subcutaneous BICX104 Pellets Compared to Vivitrol Injections

Completed
1
24
US
BICX104, Vivitrol
BioCorRx Inc, National Institute on Drug Abuse (NIDA), The HEAL Initiative (https://heal.nih.gov/)
Opioid-use Disorder
02/23
03/23
NCT05620940: A Clinical Trial to Assess Pharmacokinetic Profiles, Safety and Tolerability of IVL3004 and IVL4002 in Healthy Male Subjects.

Recruiting
1
40
RoW
Vivitrol Injectable Product, IVL3004, IVL4002
Inventage Lab., Inc.
Opioid Dependence, Alcohol Dependence
05/25
05/25
HSC-MS-24-0024, NCT06374290: Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia

Recruiting
1
20
US
Naltrexone (Vivitrol), Bupropion
The University of Texas Health Science Center, Houston
Smoking Cessation
01/26
01/26
NCT03976258: Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV

Completed
N/A
190
US
buprenorphine/naloxone, Methadone, Naltrexone Injection, Vivitrol, Heroin
MetroHealth Medical Center, National Institute on Drug Abuse (NIDA)
HIV Infection, Opioid-use Disorder, Cardiovascular Diseases
12/22
12/22
ALKS 2680 / Alkermes
ALKS 2680-301, NCT06767683: A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Recruiting
2/3
256
Europe, US, RoW
ALKS 2680, 4mg, ALKS 2680, 6mg, ALKS 2680, 8mg, ALKS 2680, 10mg, ALKS 2680, 14mg, ALKS 2680, 18mg
Alkermes, Inc.
Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
06/28
06/28
Vibrance-1, NCT06358950: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

Active, not recruiting
2
80
Europe, US, RoW
ALKS 2680, Placebo
Alkermes, Inc.
Narcolepsy Type 1
07/25
07/25
Vibrance-2, NCT06555783: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Recruiting
2
80
Europe, US, RoW
ALKS 2680, Placebo
Alkermes, Inc.
Narcolepsy Type 2
08/25
09/25
Vibrance-3, NCT06843590: A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Recruiting
2
96
US
ALKS 2680, Placebo
Alkermes, Inc.
Idiopathic Hypersomnia
06/26
06/26
HDAC inhibitor / Alkermes
No trials found
MURA-7012 / Mural Oncology
No trials found
MURA-8518 / Mural Oncology
No trials found

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