Clinical trials: Generalized Tonic Clonic Seizure
Epilepsy
A Comparison of the Effectiveness and Safety of Topiramate and Phenytoin in Patients With New Onset Epilepsy Requiring Rapid Initiation of Antiepileptic Drug Treatment
The purpose of this study is to compare the effectiveness and safety of two treatment regimens, topiramate as compared to phenytoin, in preventing seizures in patients with new-onset epilepsy who require rapid initiation of…
- Trial name
- NCT00210782
- Testing
- topiramate, phenytoin
- Volunteers
- 262 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Epilepsies, Partial, Epilepsy, Tonic-Clonic
A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are: 1.
- Trial name
- NCT06967012
- Testing
- Oral Zonisamide Therapy
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Affiliated Hospital of Nantong University
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.
Epilepsy, Generalized
Severity: Quantifying the Severity of Generalized Tonic-clonic Seizures (GTCS) With Connected Devices
By bringing together the fields of seizure detection and that of Sudden Unexpected Death in Epilepsy (SUDEP), the current project aims at delineating which set of biosensors and related biomarkers would optimally characterize the…
- Trial name
- NCT05477121
- Where
- Switzerland
- Volunteers
- 400 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Epilepsy
Evaluation and Treatment of Patients With Epilepsy
This protocol has three purposes: 1) to screen patients with seizures for participation in research studies of NINDS s Clinical Epilepsy Section (CES), 2) to follow the natural course of seizure disorders, and 3) to train CES…
- Trial name
- NCT00013845
- Where
- United States
- Volunteers
- 1,278 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
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
A Study of Fycompa (Perampanel) in Korean Participants
The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse…
- Trial name
- NCT02722590
- Where
- 9 sites in South Korea
- Volunteers
- 3,692 people
- Sponsor
- Eisai Korea 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, Generalized Tonic-Clonic Seizures
Detecting Generalized Tonic-Clonic Seizures With a Seizure Detection and Warning System in Epilepsy Patients
Prospective study of an electromyography (EMG) based seizure detection and warning system for detecting generalized tonic-clonic (GTC) seizures.
- Trial name
- NCT02371200
- Testing
- Brain Sentinel Seizure Detection and Warning System
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Brain Sentinel
CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
This is a Phase 3 Study to examine the efficacy and safety of ZX008 in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
- Conditions
- CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure, Epileptic Spasm, Refractory Seizures
- Trial name
- GEMZ (NCT05064878)
- Testing
- Fenfluramine
- Where
- 46 sites in United States, Austria and 12 more
- Volunteers
- 87 people
- Sponsor
- Zogenix, Inc.
Epilepsy, Tonic-Clonic
Embrace and Quality of Life
A prospective, open, randomized, pilot clinical trial which aims the assessment of quality of life (QOL) in epilepsy outpatients equipped with a wrist-worn biosensor that provides measures of electrodermal activity and…
- Trial name
- EMBQL (NCT03831802)
- Testing
- Embrace with Alert and Mate apps, Embrace with Mate app only
- Where
- Switzerland
- Volunteers
- 26 people
- Sponsor
- Centre Hospitalier Universitaire Vaudois
Partial Seizures (With or Without Secondary Generalized Seizures), Primary Generalized Tonic-clonic Seizures
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures
The objective of this study is to identify the following in adolescent epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive…
- Trial name
- FYC02T (NCT03059381)
- Testing
- Fycompa
- Where
- 2 sites in Japan
- Volunteers
- 519 people
- Sponsor
- Eisai Co., Ltd.
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.
Epilepsy, Tonic-Clonic
Treatment Of Primary Generalized Tonic-Clonic Seizures With An Investigational New Drug
The purpose of this study is to evaluate the effectiveness and safety of an investigational new drug for supplemental therapy in subjects with primary generalized tonic-clonic (PGTC) seizures.
- Trial name
- NCT00043901
- Testing
- lamotrigine
- Where
- 87 sites in United States, Argentina and 2 more
- Volunteers
- 141 people
- Sponsor
- GlaxoSmithKline
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
Cenobamate Open-Label Extension Study for YKP3089C025
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
- Trial name
- NCT03961568
- Testing
- Cenobamate
- Where
- 45 sites in United States, Bulgaria and 5 more
- Volunteers
- 147 people
- Sponsor
- SK Life Science, Inc.
Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures
A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures
The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures [including secondarily generalized seizures]) (age 4 years or older) or…
- Trial name
- NCT06657378
- Testing
- No Intervention
- Where
- Japan
- Volunteers
- 110 people
- Sponsor
- Eisai Co., Ltd.
Epilepsy
Transcutaneous Non-invasive Stimulation of the Vagus Nerve for the Treatment of Difficult-to-treat Epilepsy
The aim of the study is to prove the feasibility and safety of transcutaneous, electrical stimulation of the vagus nerve in patients with difficult-to-treat forms of epilepsy.
- Trial name
- NCT01178437
- Testing
- T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)
- Where
- Germany
- Volunteers
- 7 people
- Sponsor
- cerbomed GmbH