Clinical trials: Generalized Tonic Clonic Seizure
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
Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects >= 4 years of age with idiopathic generalized epilepsy…
- Trial name
- VALUE (NCT02408549)
- Testing
- Lacosamide Tablet, Lacosamide Oral Solution
- Where
- 87 sites in United States, Australia and 19 more
- Volunteers
- 239 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Healthy
A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.
- Trial name
- NCT01355068
- Testing
- Epanutin Infatabs (Phenytoin), Dilantin Infatabs (Phenytoin)
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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
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.
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.
Dravet Syndrome
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
- Trial name
- NCT02823145
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 67 sites in United States, Australia and 10 more
- Volunteers
- 375 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Drug Resistant Epilepsy, Drop Seizures
Novel Helmet Design in Patients With Seizures
This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qualitative patient reporting.
- Conditions
- Drug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure, Complex Partial Seizure
- Trial name
- NCT03443388
- Testing
- Hövding inflatable helmet
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Michael A. Gelfand, MD, PhD
Partial Onset Seizures, Secondarily Generalized Seizures
Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures.
- Conditions
- Partial Onset Seizures, Secondarily Generalized Seizures, Primary Generalized Tonic-Clonic Seizures
- Trial name
- NCT03288129
- Testing
- Perampanel
- Where
- 24 sites in United States
- Volunteers
- 54 people
- Sponsor
- Eisai Inc.
Dravet Syndrome
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
This is an exploratory sub-study to ZX008-1503 [NCT02823145]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.
- Trial name
- NCT03299842
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Epilepsy, Idiopathic Generalized
Levetiracetam Versus Valproate in Idiopathic Generalized Tonic-clonic Seizures
This study is an open-label, active-controlled,non-inferiority trial comparing efficacy and safety of levetiracetam versus valproate in idiopathic generalized tonic-clonic epilepsy.
- Trial name
- NCT03940326
- Testing
- Levetiracetam, Valproate
- Where
- Iran
- Volunteers
- 103 people
- Sponsor
- Mazandaran University of Medical Sciences
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.
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.
Tonic-clonic Seizure
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures
This study is looking at three seizure medicines. Patients with seizures are usually treated with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or by mouth.
- Trial name
- NCT00510783
- Testing
- Keppra, Fosphenytoin, Dilantin
- Where
- United States
- Volunteers
- 158 people
- Sponsor
- Emory University
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, 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
Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
The purpose is to assess the safety of Lacosamide in subjects with uncontrolled Primary Generalized Tonic-Clonic (PGTC) seizures with Idiopathic Generalized Epilepsy.
- Trial name
- NCT01118949
- Testing
- Lacosamide
- Where
- 25 sites in United States
- Volunteers
- 49 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.
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, Partial Seizures, Epilepsy, Primary Generalized Tonic-Clonic Seizures
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult…
- Trial name
- NCT01463306
- Testing
- Pregabalin
- Where
- 151 sites in United States, Belarus and 29 more
- Volunteers
- 605 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.