Clinical trials: Generalized Seizure
Epilepsy
Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures.
- Trial name
- NCT00692003
- Testing
- Zonisamide
- Where
- 73 sites in Australia, Croatia and 11 more
- Volunteers
- 21 people
- Sponsor
- Eisai Limited
Generalized Tonic Clonic Seizures
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.
The study is designed to evaluate the safety, tolerability and efficacy of two doses of pregabalin as add-on treatment in pediatric and adult subjects with Primary Generalized Tonic-Clonic (PGTC) seizures as compared to placebo.
- Trial name
- NCT01747915
- Testing
- Pregabalin Dose Level 1, Pregabalin Dose Level 2
- Where
- 127 sites in United States, Austria and 24 more
- Volunteers
- 219 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy
Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy.
- Trial name
- NCT01118962
- Testing
- Lacosamide
- Where
- 19 sites in United States
- Volunteers
- 39 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Epilepsies, Partial
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 [NCT00160165] or N01221 [NCT00280696].
- Trial name
- NCT00367432
- Testing
- Levetiracetam
- Where
- 53 sites in Japan
- Volunteers
- 398 people
- Sponsor
- UCB Japan Co. Ltd.
Seizures, Epilepsies, Partial
Efficacy and Safety of Diazepam in the Management of Refractory Epilepsy in Selected Patients Who Require Intermittent Medical Intervention for Acute Repetitive Seizures.
To evaluate the efficacy and safety of diazepam in the management of refractory epilepsy in selected patients who require intermittent medical intervention for the control of episodes of acute repetitive seizures.
- Conditions
- Seizures, Epilepsies, Partial, Epilepsy, Complex Partial, Epilepsy, Generalized
- Trial name
- NCT00319501
- Testing
- Vanquix Auto-Injector (Diazepam Injection)
- Where
- 86 sites in United States
- Volunteers
- 234 people
- Sponsor
- Pfizer
Epilepsy, Seizures
A Study of Intravenous Perampanel in Japanese Participants With Epilepsy
The purpose of the study is to evaluate the safety and tolerability of perampanel administered as a 30-minute intravenous infusion after switching from oral tablets (8 to 12 milligrams per day [mg/day]) as an adjunctive therapy…
- Trial name
- NCT03754582
- Testing
- Perampanel
- Where
- 13 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Eisai Co., Ltd.
Epilepsy, Monotherapy
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs)…
- Trial name
- NCT01465997
- Testing
- Lacosamide, Carbamazepine-Controlled Release (CBZ-CR)
- Where
- 150 sites in United States, Australia and 27 more
- Volunteers
- 551 people
- Sponsor
- UCB BIOSCIENCES GmbH
Epilepsy, Generalized Tonic-Clonic Seizures
A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures (Except Partial Seizures Evolving to Secondarily Generalized Seizures)
The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized…
- Trial name
- NCT01228747
- Testing
- Levetiracetam
- Where
- 58 sites in China, Japan
- Volunteers
- 361 people
- Sponsor
- UCB Japan Co. Ltd.
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
Primary Generalized Epilepsy
Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in PGTC Seizures
This trial is intended to study the safety and effectiveness of an new anti-epileptic drug (AED) on Primary Generalized Tonic-Clonic (PGTC) Seizures.
- Trial name
- NCT03678753
- Testing
- Cenobamate
- Where
- 116 sites in United States, Australia and 10 more
- Volunteers
- 169 people
- Sponsor
- SK Life Science, Inc.
Childhood Absence Epilepsy
Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the long-term safety and tolerability of Cannabidiol Oral Solution (CBD) in pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03355300
- Testing
- Cannabidiol Oral Solution
- Where
- 9 sites in United States
- Volunteers
- 11 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Epilepsy
CX-8998 for Absence Seizures
This is a Phase 2a, open-label study consisting of a screening period of up to 4 weeks and a 4-dose-titration treatment period to a dose of up to 10 mg twice daily (BID) of CX-8998, followed by a 1-week safety follow-up period…
- Trial name
- T-WAVE (NCT03406702)
- Testing
- CX-8998
- Where
- 7 sites in United States
- Volunteers
- 7 people
- Sponsor
- Jazz Pharmaceuticals
Status Epilepticus
LORA-PITA IV General Investigation
Secondary Data Collection:To confirm the effectiveness and safety profiles under the actual medical practice of LORA-PITA in Japan.
- Trial name
- NCT03905798
- Testing
- Lorazepam
- Where
- Japan
- Volunteers
- 206 people
- Sponsor
- Pfizer
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.
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.
Dravet Syndrome, Seizure Disorder
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive…
- Trial name
- NCT02682927
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 55 sites in United States, Australia and 9 more
- Volunteers
- 262 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Partial Onset Seizures
Study for Verification of Efficacy and Safety for Perampanel Monotherapy in Untreated Participants With Partial Onset Seizures (Including Secondarily Generalized Seizures (FREEDOM Study)
This study is conducted to evaluate the seizure-free rate of the 26-week Maintenance Period in untreated participants with partial onset seizures (POS).
- Trial name
- NCT03201900
- Testing
- E2007
- Where
- 38 sites in Japan, South Korea
- Volunteers
- 91 people
- Sponsor
- Eisai Co., Ltd.
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, Monotherapy
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom.
- Trial name
- SP0993 (NCT01243177)
- Testing
- Lacosamide, Carbamazepine-Controlled Release
- Where
- 184 sites in United States, Australia and 27 more
- Volunteers
- 888 people
- Sponsor
- UCB BIOSCIENCES GmbH