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
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.
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.
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.
Epilepsy
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
This is a randomized study designed to compare long-term treatment outcomes in pediatric patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus anti-epileptic drugs (AEDs).
- Trial name
- NCT01118455
- Testing
- Vagus Nerve Stimulation (VNS) Therapy, Anti-Epileptic Drug (AED)
- Where
- 19 sites in Austria, Belgium and 3 more
- Volunteers
- 134 people
- Sponsor
- Cyberonics, Inc.
Refractory Epilepsy
Thalidomide Low Threshold in Epilepsy
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.
- Trial name
- NCT01061866
- Testing
- 3-phthalimidoglutarimide (Thalidomide)
- Volunteers
- 7 people
- Sponsor
- National Institute of Neurology and Neurosurgery, Mexico
15q Duplication Syndrome, CDKL5 Deficiency Disease
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
- Trial name
- NCT03694275
- Testing
- Soticlestat
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Takeda
Epilepsy
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy…
- Trial name
- VALOR (NCT02408523)
- Testing
- Lacosamide Tablet, Lasosamide Oral Solution
- Where
- 115 sites in United States, Australia and 20 more
- Volunteers
- 242 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Subarachnoid Hemorrhage
Antiepileptic Drugs and Vascular Risk Markers
The purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.
- Trial name
- NCT00774306
- Testing
- phenytoin, valproate, levetiracetam
- Volunteers
- 52 people
- Sponsor
- Thomas Jefferson University
Epilepsy, Generalized Tonic-clonic Seizures
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic…
- Trial name
- NCT01292837
- Testing
- Levetiracetam
- Where
- 26 sites in Japan
- Volunteers
- 13 people
- Sponsor
- UCB Japan Co. Ltd.