Clinical trials: Antiepileptic Drugs
Infantile Spasms
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending…
- Trial name
- NCT00441896
- Testing
- Ganaxolone
- Where
- 15 sites in United States
- Volunteers
- 57 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy according to an initiation or a…
- Trial name
- NCT01405508
- Testing
- Brivaracetam tablets, Brivaracetam bolus, Brivaracetam infusion
- Where
- 17 sites in United States, Czechia and 2 more
- Volunteers
- 105 people
- Sponsor
- UCB Pharma
Focal Epilepsy With and Without Secondary Generalization
Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy
This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment…
- Trial name
- VICTOS (NCT01673282)
- Testing
- Lacosamide
- Where
- 42 sites in Austria, Germany
- Volunteers
- 315 people
- Sponsor
- UCB Pharma GmbH
Epilepsy, Tonic-Clonic
Study Evaluating LAMICTAL Extended-Release Therapy Added To Current Seizure Treatments In Patients With Primary Generalized Tonic-Clonic Seizures (PGTC) Seizures
This study is being conducted to compare the efficacy and safety of LAMICTAL (lamotrigine) extended-release with placebo in the treatment of Primary Generalized Tonic-Clonic (PGTC) seizures.
- Trial name
- NCT00104416
- Testing
- lamotrigine (LAMICTAL) extended-release
- Where
- 146 sites in United States, Argentina and 9 more
- Volunteers
- 153 people
- Sponsor
- GlaxoSmithKline
Epilepsy, Partial Seizures
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with…
- Trial name
- NCT01063764
- Testing
- Levetiracetam
- Where
- 29 sites in Japan
- Volunteers
- 73 people
- Sponsor
- UCB Japan Co. Ltd.
Dravet Syndrome
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet…
- Trial name
- NCT02926898
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 87 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Focal Epilepsy
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination…
- Trial name
- NCT00855738
- Testing
- Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
- Volunteers
- 111 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsies, Partial
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures
SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with…
- Trial name
- PASS (NCT00771927)
- Testing
- Lacosamide
- Where
- 62 sites in France, Germany and 3 more
- Volunteers
- 1,005 people
- Sponsor
- UCB Pharma
Epilepsy, Dravet Syndrome
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
- Trial name
- NCT02091375
- Testing
- GWP42003-P 20 mg/kg/day Dose
- Where
- 22 sites in United States, France and 2 more
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Epilepsies, Partial
Vimpat® Added as Adjunctive Therapy to One Baseline Antiepileptic Drug
The purpose of this study is to systematically and prospectively collect data from patients with partial-onset seizures in routine clinical practice setting receiving adjunctive Vimpat®.
- Trial name
- VITOBA (NCT01098162)
- Where
- 113 sites in Germany
- Volunteers
- 576 people
- Sponsor
- UCB Pharma GmbH
Infantile Spasms
Open-label Extension to Protocol 1042-0500
To allow open-label extension to patients who have completed Protocol 1042-0500
- Trial name
- NCT00442104
- Testing
- Ganaxolone
- Where
- 14 sites in United States
- Volunteers
- 54 people
- Sponsor
- Marinus Pharmaceuticals
Partial Epilepsies, Partial Onset Seizures
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
- Trial name
- NCT00655486
- Testing
- lacosamide
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Partial Epilepsies
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy
- Trial name
- NCT00522275
- Testing
- lacosamide
- Where
- 60 sites in United States
- Volunteers
- 308 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Epilepsy
A Study to Assess Tolerability and Efficacy of Topiramate Monotherapy in Recently Diagnosed Patients With Epilepsy
The purpose of this dose optimization study is to assess tolerability and efficacy of topiramate monotherapy in recently diagnosed patients with epilepsy who are treatment naive or have failed one anti-epileptic drug (AED)…
- Trial name
- NCT01689649
- Testing
- Topiramate
- Where
- 2 sites in Vietnam
- Volunteers
- 139 people
- Sponsor
- Janssen Research & Development, LLC
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Drug Resistant Partial Onset Seizure
Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
- Trial name
- NCT01963208
- Testing
- ganaxolone
- Where
- 71 sites in United States, Australia and 4 more
- Volunteers
- 405 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy, Complex Partial
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
- Trial name
- 0602 (NCT01002820)
- Testing
- ganaxolone
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy, Partial
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
- Trial name
- NCT00152451
- Testing
- Seletracetam (ucb 44212)
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- UCB S.A. - Pharma Sector
Epilepsy With Simple or Complex Partial Onset Seizures
Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
- Trial name
- NCT00866775
- Testing
- Eslicarbazepine acetate
- Where
- 106 sites in United States, Canada
- Volunteers
- 193 people
- Sponsor
- Sumitomo Pharma America, Inc.
Partial Epilepsies
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg…
- Trial name
- SELF (NCT01235403)
- Testing
- Lacosamide
- Where
- 32 sites in France
- Volunteers
- 100 people
- Sponsor
- UCB Pharma