Clinical trials: Seizures, Tonic-Clonic
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.
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
Generalized Convulsive Epilepsy
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years)…
- Trial name
- NCT00160550
- Testing
- Levetiracetam
- Volunteers
- 154 people
- Sponsor
- UCB Pharma
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, 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, Seizures
A Study of the Efficacy and Safety of Topiramate in Epilepsy Patients With Primary Generalized Tonic-clonic Seizures
The purpose of this study is to evaluate the efficacy and safety of topiramate as an add-on therapy in epilepsy patients with uncontrolled primary generalized tonic-clonic seizures, who are taking 1 or 2 standard antiepileptic…
- Trial name
- NCT00236418
- Testing
- topiramate
- Volunteers
- 80 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
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
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.
Seizure Disorder Generalized Tonic Clonic
A Efficacy and Safety Study of Adjunctive Perampanel in Primary Generalized Tonic Clonic Seizures
This study is designed to evaluate the efficacy, safety, and pharmacokinetics (PK) of perampanel on Primary Generalized Tonic Clonic (PGTC) seizure frequency in adolescents and adults maintained on one to two stable antiepileptic…
- Trial name
- NCT01393743
- Testing
- Perampanel
- Volunteers
- 163 people
- Sponsor
- Eisai 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.
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
Partial-Onset or Primary Generalized Tonic-Clonic Seizures
Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures
This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with…
- Trial name
- NCT02849626
- Testing
- Perampanel
- Where
- 91 sites in United States, Belgium and 10 more
- Volunteers
- 180 people
- Sponsor
- Eisai Inc.
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
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.
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.
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, 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, Tonic-Clonic, Focal Seizure
Clinical Trial of Vormatrigine in Adult Patients With Epilepsy
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy
- Conditions
- Epilepsy, Tonic-Clonic, Focal Seizure, Primary Generalized Seizure
- Trial name
- NCT07287163
- Testing
- vormatrogine
- Where
- 36 sites in United States, Brazil and 4 more
- Volunteers
- 700 people
- Sponsor
- Praxis Precision Medicines
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.