Clinical trials: Seizure Disorders
Unilateral Deafness
Evaluation of BiCROS Fitting Benefits
22 candidates for BiCROS hearing aids will be recruited and fitted with a hearing aid and a CROS device. Following a real-world trial, each participant will be tested on a range of outcome measures including speech recognition in…
- Trial name
- NCT05379231
- Testing
- Hearing aid fitting
- Where
- 2 sites in Canada
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Sonova AG
Electroencephalographic Neonatal Seizures
A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures
The purpose of the study is to evaluate the pharmacokinetics (PK) of brivaracetam (BRV) in neonates who have seizures that are not adequately controlled with previous antiepileptic drug (AED) treatment, and to identify the…
- Trial name
- NCT03325439
- Testing
- Brivaracetam (BRV) intravenous (iv), Brivaracetam (BRV) oral
- Where
- 12 sites in Belgium, Czechia and 5 more
- Volunteers
- 9 people
- Sponsor
- UCB Biopharma SRL
PCDH19-Related Epilepsy
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)
A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in female children and young adults with genetically confirmed PCDH19 gene…
- Trial name
- NCT03865732
- Testing
- Ganaxolone
- Where
- 12 sites in United States, Hungary and 3 more
- Volunteers
- 29 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
- Trial name
- NCT02358538
- Testing
- Ganaxolone
- Where
- 10 sites in United States, Italy
- Volunteers
- 30 people
- Sponsor
- Marinus Pharmaceuticals
Infantile Spasms
Phase 3 Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms: Open-label Extension Phase (GWPCARE7)
This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The open-label extension phase only will be described in this record.
- Trial name
- NCT02954887
- Testing
- GWP42003-P
- Where
- 7 sites in United States, Poland
- Volunteers
- 9 people
- Sponsor
- Jazz Pharmaceuticals
Epilepsy
Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures.
- Trial name
- NCT00692003
- Testing
- Zonisamide
- Where
- 73 sites in Australia, Croatia and 11 more
- Volunteers
- 21 people
- Sponsor
- Eisai Limited
Epilepsy
Long-Term Safety Study of Retigabine Immediate Release (IR) as Adjunctive Therapy in the Treatment of Adults With Partial-Onset Seizures (POS)
The purpose of this Phase III study is to assess the long-term safety, tolerability and efficacy of flexibly dosed retigabine Immediate Release (IR) as adjunctive therapy in adult subjects with partial-onset seizures.
- Trial name
- IR (NCT01336621)
- Testing
- Retigabine IR
- Where
- 31 sites in Belgium, Bulgaria and 8 more
- Volunteers
- 98 people
- Sponsor
- GlaxoSmithKline
Seizures
Retigabine Efficacy and Safety Trial for Partial Onset Refractory Seizures in Epilepsy
This Phase 3 study is being conducted to evaluate the efficacy and safety of retigabine dosed at 900 mg/day and 600 mg/day, in three equally divided doses, compared with placebo in patients with epilepsy who are receiving up to…
- Trial name
- RESTORE2 (NCT00235755)
- Testing
- Retigabine
- Where
- 70 sites in United States, Australia and 11 more
- Volunteers
- 539 people
- Sponsor
- GlaxoSmithKline
Central Nervous System
Pharmacokinetics, Efficacy, and Safety of Perampanel Oral Suspension on Seizure Frequency in Pediatric Subjects Maintained on One to Three Stable Antiepileptic Drugs
This study is designed to evaluate the pharmacokinetics, efficacy, and safety of perampanel oral suspension on seizure frequency in pediatric participants maintained on one to three stable antiepileptic drugs
- Trial name
- NCT01527006
- Testing
- perampanel
- Where
- 23 sites in United States
- Volunteers
- 63 people
- Sponsor
- Eisai Inc.
Epilepsy
Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites
The purpose of this study is to determine the effects of age on the pharmacokinetic profile of BIA 2-093 and its active metabolites.
- Trial name
- NCT02172755
- Testing
- BIA 2-093
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Epilepsies, Partial
Open-label Extension to Protocol 1042-0600
To allow open-label extension to patients who have completed Protocol 1042-0600.
- Trial name
- NCT00512317
- Testing
- ganaxolone
- Where
- 25 sites in United States
- Volunteers
- 123 people
- Sponsor
- Marinus Pharmaceuticals
Seizure Disorders
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.
- Trial name
- FruitiVits (NCT02229318)
- Testing
- FruitiVits
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Vitaflo International, Ltd
Epilepsy
RNS® System Pivotal Study
The RNS® System Pivotal study is designed to assess safety and demonstrate that the RNS® System is effective as an adjunctive (add-on) therapy in reducing the frequency of seizures in individuals 18 years of age or older with…
- Trial name
- NCT00264810
- Testing
- RNS® System implantation, RNS® System responsive stimulation
- Where
- 32 sites in United States
- Volunteers
- 240 people
- Sponsor
- NeuroPace
Epilepsy, Partial
Study Of The Safety And Efficacy Of Lyrica In The Treatment Of Newly Diagnosed Partial Epilepsy
The purpose of this study is to assess whether Lyrica is a safe and effective treatment for partial epilepsy in comparison with an established treatment, Lamictal.
- Trial name
- NCT00280059
- Testing
- Pregabalin, Lamotrigine
- Where
- 102 sites in Belgium, Bulgaria and 27 more
- Volunteers
- 660 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy
A Long-term Safety and Tolerability Study of USL261 in Patients With Seizure Clusters
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
- Trial name
- NCT02161185
- Testing
- USL261
- Where
- 16 sites in United States
- Volunteers
- 7 people
- Sponsor
- UCB Biopharma S.P.R.L.
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
Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy
The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute infusion to adult patients with epilepsy on stable…
- Trial name
- NCT01128959
- Testing
- Intravenous Carbamazepine (IV CBZ)
- Where
- 29 sites in United States
- Volunteers
- 108 people
- Sponsor
- Lundbeck LLC
Episodic Migraine
12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine
To evaluate the safety and tolerability of atogepant 30 mg and 60 mg once a day for the prevention of migraine in participants with episodic migraine.
- Trial name
- NCT03777059
- Testing
- Atogepant
- Where
- 138 sites in United States
- Volunteers
- 910 people
- Sponsor
- Allergan
Highly Drug-resistant Focal Epilepsy
An Open-label Extension Study of UCB0942 in Adult Patients With Highly Drug-resistant Focal Epilepsy
The purpose of study EP0073 is to assess the long-term safety, tolerability, and efficacy during 5 years of treatment with the drug UCB0942 in patients with highly drug-resistant focal epilepsy.
- Trial name
- NCT02625090
- Testing
- UCB0942
- Where
- 15 sites in Belgium, Bulgaria and 4 more
- Volunteers
- 42 people
- Sponsor
- UCB Biopharma SRL
Healthy Subjects, Renal Impairments
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects with various degrees of…
- Trial name
- NCT01491113
- Testing
- Levetiracetam 250 mg, Levetiracetam 500 mg
- Where
- 2 sites in Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- UCB Pharma