Clinical trials: Tonic-Clonic Seizures
Epilepsy, Seizures
Assessment of the Emfit Mattress Sensor for Detection and Alarm of Night-time Generalized Tonic-clonic Seizures.
Sudden unexpected death in epilepsy (SUDEP) is the most important epilepsy-related mode of death. The exact mechanism of SUDEP is not known. It is thought that cardiac and respiratory factors are involved.
- Trial name
- NCT02661919
- Testing
- Emfit mattress sensor
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Emfit, Corp.
Epilepsy
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in patients receiving LCM in SP0994 [NCT01465997].
- Trial name
- NCT02582866
- Testing
- Lacosamide
- Where
- 46 sites in Bulgaria, Finland and 13 more
- Volunteers
- 106 people
- Sponsor
- UCB Biopharma S.P.R.L.
Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome
An Extended Access Program (EAP) for Perampanel
The main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time…
- Trial name
- NCT02307578
- Testing
- Perampanel
- Where
- 27 sites in Belgium, Chile and 8 more
- Sponsor
- Eisai Inc.
Focal Onset Seizure, Primary Generalized Epilepsy
An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures
- Trial name
- NCT06908356
- Testing
- 30mg PRAX-628
- Where
- 11 sites in United States, Australia and 1 more
- Volunteers
- 50 people
- Sponsor
- Praxis Precision Medicines
Epilepsy
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
The primary purpose of this study is to evaluate the efficacy of perampanel monotherapy measured by the seizure-free rate during the Maintenance Period (24 weeks) of the Treatment Phase in untreated participants with focal onset…
- Trial name
- NCT05533814
- Testing
- Perampanel
- Where
- 10 sites in South Korea
- Volunteers
- 125 people
- Sponsor
- Eisai Korea Inc.
Seizures, Epilepsy
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures
The purpose of this observational study is to evaluate the safety of topiramate when used in combination with other medications for seizures in adults and children.
- Trial name
- NCT00297349
- Testing
- Topiramate
- Volunteers
- 153 people
- Sponsor
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
Epilepsy, Idiopathic Generalized Epilepsy
RNS System NAUTILUS Study
To demonstrate that the RNS System for thalamic stimulation is safe and effective as an adjunctive therapy for the reduction of primary generalized seizures in individuals 12 years of age or older who have drug-resistant…
- Conditions
- Epilepsy, Idiopathic Generalized Epilepsy, Generalized Tonic Clonic Seizure
- Trial name
- NAUTILUS (NCT05147571)
- Testing
- Responsive stimulation
- Where
- 23 sites in United States
- Volunteers
- 100 people
- Sponsor
- NeuroPace
Generalized Epilepsy
Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy
A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized…
- Trial name
- NCT00150735
- Testing
- LEVETIRACETAM
- Volunteers
- 580 people
- Sponsor
- UCB Pharma
Epilepsies, Partial
Compassionate Use Program With Lacosamide in Patients With Partial-onset or Generalized Tonic-clonic Seizures
The objective of this Compassionate Use Program (CUP) is to provide continued access to Lacosamide (LCM) for monotherapy use for patients who were receiving LCM in SP0993 and SP0994 at the time of study unblinding and close of…
- Trial name
- NCT03559673
- Testing
- Lacosamide
- Sponsor
- UCB Biopharma S.P.R.L.
Seizures
A Study to Evaluate the Effectiveness of Perampanel as Only Add-on Treatment in Participants With Primary or Secondarily Generalized Tonic-clonic Seizures
The primary purpose of this study is to investigate the effectiveness reflected by the retention rate of perampanel as the only add-on treatment in adult participants with primary generalized tonic-clonic (PGTC) or secondarily…
- Trial name
- NCT04202159
- Testing
- Perampanel
- Where
- 34 sites in Germany
- Volunteers
- 187 people
- Sponsor
- Eisai GmbH
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.
Idiopathic Generalized Epilepsy, Partial Onset Seizures
A Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Add-on Therapy in Participants >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial…
- Conditions
- Idiopathic Generalized Epilepsy, Partial Onset Seizures, Generalised Tonic-Clonic Seizures
- Trial name
- NCT04252846
- Testing
- Perampanel
- Where
- 36 sites in Denmark, France and 5 more
- Volunteers
- 191 people
- Sponsor
- Eisai Limited
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
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.
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.
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.