- |||||||||| Trileptal (oxcarbazepine) / Novartis
Journal: Therapeutic Drug Monitoring of Antiepileptic Drugs in Epilepsy: A 2018 Update. (Pubmed Central) - Apr 30, 2019 For the older first generation AEDs (carbamazepine, ethosuximide, phenobarbital, phenytoin, primidone and valproic acid), much data has accumulated in this regard. However, this is occurring increasingly for the new AEDs (brivaracetam, eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, piracetam, pregabalin, rufinamide, stiripentol, sulthiame, tiagabine, topiramate, vigabatrin and zonisamide).
- |||||||||| zonisamide / generics, levetiracetam / generics, topiramate / generics
Clinical, Journal: The course and development of epilepsy in patients with typical variant of Rett syndrome and mutations (Pubmed Central) - Apr 10, 2019 One patient with resistant epilepsy was treated with the combination of drugs (levetiracetam, topiramate, zonisamide, benzodiazepine) that led to stopping of seizures during night sleep and decrease in the frequency of daytime seizures by 50%. Further research of epilepsy and efficacy of antiepileptic drugs in Rett syndrome is required.
- |||||||||| carbamazepine / generics
Journal: Making Rash Decisions in Epilepsy: Evaluating Hypersensitivity Reactions to Anti-seizure Medications. (Pubmed Central) - Apr 9, 2019 Although AEDs as a class were associated with 9 times the risk of SJS/TEN compared with non-AEDs, there were 6 AEDs with risk estimates greater than 20. Increased awareness of this risk among both prescribers and patients, particularly variations in risk among different AEDs, along with education on early recognition of SJS/TEN signs/symptoms, may help mitigate the number and severity of these adverse events.
- |||||||||| zonisamide / generics
Clinical, Journal: The course and the development of epilepsy in patients with typical variant of Rett syndrome and mutations (Pubmed Central) - Apr 7, 2019 one patients with resistant epilepsy was taken combination of drugs (levetirecetam, topiromat, zonisamide, benzodiazepine) with stopping of seizures in the night sleep and decreasing of frequency of daytime seizures to 50%. We believe there is very important of study epilepsy in patients with Rett syndrome and improvement of its treatment.
- |||||||||| zonisamide / generics
Clinical, Retrospective data, Journal: Efficacy, tolerability, and blood concentration of zonisamide in daily clinical practice. (Pubmed Central) - Apr 3, 2019 The number, mechanism of action, or drug load of the AEDs did not predict the development of AEs; however, blood concentration of ZNS was significantly higher in patients with AEs (p = 0.0011) than in those without AEs. ZNS is a well-tolerated and effective AED in daily clinical practice, and several clinical factors may predict the efficacy and tolerability of ZNS.
- |||||||||| zonisamide / Generic mfg.
Enrollment open: Zonisamide Outpatient Study (clinicaltrials.gov) - Mar 12, 2019 P2, N=60, Recruiting, ZNS is a well-tolerated and effective AED in daily clinical practice, and several clinical factors may predict the efficacy and tolerability of ZNS. Not yet recruiting --> Recruiting
- |||||||||| zonisamide / Generic mfg.
Trial completion date, Trial initiation date, Trial primary completion date: Zonisamide Outpatient Study (clinicaltrials.gov) - Jan 7, 2019 P2, N=60, Not yet recruiting, Trial primary completion date: Oct 2019 --> Oct 2018 Trial completion date: Mar 2020 --> Aug 2020 | Initiation date: Oct 2018 --> Jan 2019 | Trial primary completion date: Mar 2019 --> Aug 2019
- |||||||||| zonisamide / Generic mfg.
Enrollment closed: Effectiveness of Zonisamide in Alcohol Dependent Veterans (clinicaltrials.gov) - Nov 30, 2018 P3, N=160, Active, not recruiting, Trial completion date: Mar 2020 --> Aug 2020 | Initiation date: Oct 2018 --> Jan 2019 | Trial primary completion date: Mar 2019 --> Aug 2019 Recruiting --> Active, not recruiting
- |||||||||| Review, Journal: Future Pharmacotherapy for Obesity: New Anti-obesity Drugs on the Horizon. (Pubmed Central) - Oct 4, 2018
This review focuses on anti-obesity drugs in the pipeline including centrally acting agents (setmelanotide, neuropeptide Y antagonist [velneperit], zonisamide-bupropion [Empatic], cannabinoid type-1 receptor blockers), gut hormones and incretin targets (new glucagon-like-peptide-1 [GLP-1] analogues [semaglutide and oral equivalents], amylin mimetics [davalintide, dual amylin and calcitonin receptor agonists], dual action GLP-1/glucagon receptor agonists [oxyntomodulin], triple agonists [tri-agonist 1706], peptide YY, leptin analogues [combination pramlintide-metreleptin]), and other novel targets (methionine aminopeptidase 2 inhibitor [beloranib], lipase inhibitor [cetilistat], triple monoamine reuptake inhibitor [tesofensine], fibroblast growth factor 21), including anti-obesity vaccines (ghrelin, somatostatin, adenovirus36). With these new drugs in development, anti-obesity therapeutics have potential to vastly expand allowing better treatment options and personalized approach to obesity care.
- |||||||||| zonisamide / Generic mfg.
Trial completion date, Trial initiation date, Trial primary completion date: Zonisamide Outpatient Study (clinicaltrials.gov) - Sep 27, 2018 P2, N=60, Not yet recruiting, With these new drugs in development, anti-obesity therapeutics have potential to vastly expand allowing better treatment options and personalized approach to obesity care. Trial completion date: Jan 2020 --> Mar 2020 | Initiation date: Jan 2018 --> Oct 2018 | Trial primary completion date: Aug 2018 --> Mar 2019
- |||||||||| zonisamide / Generic mfg.
New P2 trial: Zonisamide Outpatient Study (clinicaltrials.gov) - Dec 18, 2017 P2, N=60, Not yet recruiting,
- |||||||||| zonisamide / Generic mfg.
Enrollment change, Trial initiation date, Trial withdrawal, Trial primary completion date: Prevention of Noise-induced Hearing Loss (clinicaltrials.gov) - Nov 6, 2017 P1/2, N=0, Withdrawn, Trial primary completion date: Sep 2017 --> Oct 2019 N=50 --> 0 | Initiation date: Jun 2017 --> Oct 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2019 --> Nov 2017 | N=50 --> 0 | Initiation date: Jun 2017 --> Oct 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2019 --> Nov 2017
- |||||||||| Enrollment open, Adverse events: BEEP2b: Characterization of Epilepsy Patients BEEP 2b (clinicaltrials.gov) - Aug 3, 2017
P4, N=12, Enrolling by invitation, N=50 --> 0 | Initiation date: Jun 2017 --> Oct 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2019 --> Nov 2017 | N=50 --> 0 | Initiation date: Jun 2017 --> Oct 2017 | Not yet recruiting --> Withdrawn | Trial primary completion date: Dec 2019 --> Nov 2017 Not yet recruiting --> Enrolling by invitation
- |||||||||| Fycompa (perampanel) / Eisai, Catalyst Pharma, Ospolot (sultiam) / AOP Orphan Pharma, Diacomit (stiripentol) / Biocodex, Meiji Seika
Enrollment open: EPIPOP: Population Pharmacokinetics of Antiepileptic in Pediatrics (clinicaltrials.gov) - Jul 4, 2017 P=N/A, N=1000, Recruiting, Initiation date: Sep 2016 --> Aug 2017 Not yet recruiting --> Recruiting
- |||||||||| Phase classification, Trial initiation date, Adverse events: BEEP2b: Characterization of Epilepsy Patients BEEP 2b (clinicaltrials.gov) - May 8, 2017
P4, N=12, Not yet recruiting, N=200 --> 74 Phase classification: P=N/A --> P4 | Initiation date: Apr 2017 --> Jul 2017
- |||||||||| Nitredon (nitrazepam) / Remedica, Diacomit (stiripentol) / Biocodex, Meiji Seika
Trial primary completion date: Ketogenic Diet in Infants With Epilepsy (KIWE) (clinicaltrials.gov) - May 3, 2017 P4, N=160, Recruiting, Phase classification: P=N/A --> P4 | Initiation date: Apr 2017 --> Jul 2017 Trial primary completion date: Jan 2018 --> Jun 2018
- |||||||||| Trial initiation date, Trial primary completion date, Adverse events: BEEP2b: Characterization of Epilepsy Patients BEEP 2b (clinicaltrials.gov) - Feb 28, 2017
P=N/A, N=12, Not yet recruiting, Trial primary completion date: Jan 2018 --> Jun 2018 Initiation date: Mar 2016 --> Apr 2017 | Trial primary completion date: Dec 2016 --> Dec 2017
- |||||||||| Nitredon (nitrazepam) / Remedica, Diacomit (stiripentol) / Biocodex, Meiji Seika
Enrollment open, Trial primary completion date: Ketogenic Diet in Infants With Epilepsy (KIWE) (clinicaltrials.gov) - Apr 28, 2016 P4, N=160, Recruiting, Trial primary completion date: Dec 2015 --> Sep 2017 Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2017 --> Jan 2018
- |||||||||| zonisamide / Generic mfg.
Enrollment change, Trial termination: Zonisamide for Heavy Drinkers With Bipolar Disorder (clinicaltrials.gov) - Jan 7, 2016 P2, N=3, Terminated, Not yet recruiting --> Recruiting | Trial primary completion date: Jun 2017 --> Jan 2018 N=40 --> 3 | Recruiting --> Terminated; recruitment infeasible
- |||||||||| zonisamide / Generic mfg.
Trial primary completion date: Zonisamide for Heavy Drinkers With Bipolar Disorder (clinicaltrials.gov) - Jul 15, 2015 P2, N=40, Recruiting, Trial primary completion date: Sep 2014 --> Dec 2015 Trial primary completion date: Apr 2015 --> Apr 2016
- |||||||||| zonisamide / Generic mfg.
Trial completion, Enrollment change, Trial primary completion date: EpsilonZ (clinicaltrials.gov) - Apr 25, 2015 P3, N=24, Completed, Trial primary completion date: Apr 2015 --> Apr 2016 Recruiting --> Completed | N=32 --> 24 | Trial primary completion date: Feb 2015 --> Jul 2014
- |||||||||| zonisamide / Generic mfg., levetiracetam / Generic mfg., topiramate / Generic mfg.
Enrollment change, Trial termination, Trial primary completion date: Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism (clinicaltrials.gov) - Apr 7, 2015 P2, N=85, Terminated, Recruiting --> Completed | N=32 --> 24 | Trial primary completion date: Feb 2015 --> Jul 2014 N=160 --> 85 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2014 --> Aug 2013; Recruitment goals could not be met before ending of funding for this project.
- |||||||||| zonisamide / Generic mfg.
Trial termination, Trial primary completion date: Zonisamide in the Treatment of Essential Tremor (clinicaltrials.gov) - Jul 17, 2014 P=N/A, N=9, Terminated, N=160 --> 85 | Active, not recruiting --> Terminated | Trial primary completion date: Mar 2014 --> Aug 2013; Recruitment goals could not be met before ending of funding for this project. Active, not recruiting --> Terminated | Trial primary completion date: May 2008 --> Oct 2012; Principal Investigator left the study site on December 28, 2012.
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