Clinical trials: Epilepsy, Generalized
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Infantile Spasms
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record.
- Trial name
- NCT02953548
- Testing
- GWP42003-P
- Where
- 8 sites in United States, Poland
- Volunteers
- 9 people
- Sponsor
- Jazz Pharmaceuticals
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.
Mitochondrial Diseases, Drug Resistant Epilepsy
A Study to Evaluate Efficacy and Safety of Vatiquinone for Treating Mitochondrial Disease in Participants With Refractory Epilepsy
This is a parallel-arm, double-blind, placebo-controlled study with a screening phase that includes a 28-day run-in phase to establish baseline seizure frequency, followed by a 24-week, randomized, placebo-controlled phase.
- Conditions
- Mitochondrial Diseases, Drug Resistant Epilepsy, Leigh Disease, Leigh Syndrome
- Trial name
- MIT-E (NCT04378075)
- Testing
- Vatiquinone
- Where
- 27 sites in United States, Canada and 7 more
- Volunteers
- 68 people
- Sponsor
- PTC Therapeutics
Epilepsy
Fycompa Titration Intervals and Effects on Retention Rate
This study will aim to improve retention and tolerability by slowing the initial titration rate of perampanel from a standard up-titration rate of 2 week intervals to a slower up-titration rate consisting of 3 week intervals.
- Trial name
- NCT03457129
- Testing
- Perampanel Oral Tablet
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Arizona
Childhood Absence Epilepsy
Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures
The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures.
- Trial name
- NCT03336242
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 20 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Epilepsy, Dravet Syndrome
A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)
To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.
- Trial name
- NCT02091206
- Testing
- GWP42003-P 5 mg/kg/day Dose, GWP42003-P 10 mg/kg/day Dose, GWP42003-P 20 mg/kg/day Dose
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 34 people
- Sponsor
- Jazz Pharmaceuticals
Infantile Spasms
Open-label Extension to Protocol 1042-0500
To allow open-label extension to patients who have completed Protocol 1042-0500
- Trial name
- NCT00442104
- Testing
- Ganaxolone
- Where
- 14 sites in United States
- Volunteers
- 54 people
- Sponsor
- Marinus Pharmaceuticals
Infantile Spasm
A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms
The primary purpose of this study was to evaluate the efficacy, safety, and tolerability of Cannabidiol Oral Solution (CBD) as adjunctive therapy with vigabatrin as initial therapy, compared to vigabatrin alone in the treatment…
- Trial name
- NCT03421496
- Testing
- Cannabidiol Oral Solution, Vigabatrin
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Radius Pharmaceuticals, Inc.
Lennox-Gastaut Syndrome, Dravet Syndrome
The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy
The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical function and the autonomic nervous system in children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), when the CBD is…
- Trial name
- CBD1 (NCT02815540)
- Testing
- 12-Lead ECG, Cannabidiol
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Gillette Children's Specialty Healthcare
Epilepsy
Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
This study is intended to provide evidence that zonisamide is safe and effective in the treatment of myoclonic seizures. The total planned trial duration will be 6.5 months.
- Trial name
- NCT00693017
- Testing
- Zonisamide
- Where
- 72 sites in Australia, Croatia and 11 more
- Volunteers
- 10 people
- Sponsor
- Eisai Limited
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
Renal Pelvis Cancer, Restless Legs Syndrome
Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)
High doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in the Adverse Events…
- Conditions
- Renal Pelvis Cancer, Restless Legs Syndrome, Epilepsy, Neuropathic Pain
- Trial name
- NCT01138124
- Testing
- Gabapentin prescriptions
- Volunteers
- 54,202 people
- Sponsor
- GlaxoSmithKline
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine
The purpose of this study is to check how soticlestat impacts symptoms of Dravet syndrome [DS] and Lennox-Gastaut syndrome [LGS] in participants who have been exposed to fenfluramine.
- Trial name
- NCT06422377
- Testing
- Soticlestat
- Where
- Denmark
- Volunteers
- 1 people
- Sponsor
- Takeda
Epilepsy, Tonic-clonic
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
- Trial name
- NCT00150813
- Testing
- Levetiracetam
- Where
- 21 sites in Czechia, Hungary and 2 more
- Volunteers
- 66 people
- Sponsor
- UCB Pharma SA
Dravet Syndrome
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
To investigate the long-term safety and tolerability of clobazam when administered for 1 year as adjunctive therapy in paediatric patients aged ≥1 to ≤16 years with Dravet Syndrome.
- Trial name
- NCT02187809
- Testing
- Clobazam
- Where
- 9 sites in United States, Mexico
- Volunteers
- 3 people
- Sponsor
- H. Lundbeck A/S
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.
Seizures Associated With EMAS
Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
The primary aim of Part A of the study to assess the efficacy and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures.
- Trial name
- NCT05288283
- Testing
- GWP42003-P
- Where
- 14 sites in United States, Italy
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Epilepsy, Dravet Syndrome
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
- Trial name
- NCT02224703
- Testing
- GWP42003-P
- Where
- 38 sites in United States, Australia and 4 more
- Volunteers
- 199 people
- Sponsor
- Jazz Pharmaceuticals
Myoclonus Epilepsies, Progressive
Safety, Blood Levels and Effects of AUT00201 in Patients With MEAK
A randomized, double-blind, placebo-controlled, crossover study to assess the safety, tolerability, and pharmacokinetics of single doses of AUT00201 at 100 mg or matching placebo in patients with myoclonus epilepsy and ataxia due…
- Trial name
- AUT022201 (NCT05873062)
- Testing
- AUT00201
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Autifony Therapeutics Limited