Clinical trials: CDKL5
Dravet Syndrome
ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome
The primary purpose of this study is to evaluate the safety and tolerability of ION337 in participants with Dravet syndrome (DS).
- Trial name
- NCT07531745
- Testing
- ION337
- Where
- 6 sites in United States, Canada
- Volunteers
- 32 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Dravet Syndrome, Lennox Gastaut Syndrome
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).
- Trial name
- NCT03467113
- Testing
- ZX008 0.2 to 0.8 mg/kg/day, Cannabidiol
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
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
CDKL5 Disorder
Ganaxolone Expanded Access Program Compassionate Use
The primary objective is to provide GNX to patients ≥ 2 years with CDD-related seizures who are refractory to, or intolerant of, standard therapy.
- Trial name
- CDD (NCT04678479)
- Testing
- Ganaxolone
- Sponsor
- Marinus Pharmaceuticals
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 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.
Dravet Syndrome, Lennox Gastaut Syndrome
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
- Conditions
- Dravet Syndrome, Lennox Gastaut Syndrome, Epileptic Encephalopathy
- Trial name
- NCT03936777
- Testing
- ZX008 (Fenfluramine Hydrochloride)
- Where
- 71 sites in United States, Australia and 12 more
- Volunteers
- 412 people
- Sponsor
- Zogenix, Inc.
Dravet Syndrome
Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects.
This is a placebo-controlled, double-blind, 2-period study in 3 sequential groups of 8 healthy subjects each. The safety and pharmacokinetics of escalating single and multiple oral doses of EPX-100 will be assessed in fasting…
- Trial name
- NCT04069689
- Testing
- EPX-100 (Clemizole Hydrochloride)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Epygenix
Dravet Syndrome (DS)
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS.
- Trial name
- NCT04940624
- Testing
- Soticlestat
- Where
- 66 sites in United States, Australia and 16 more
- Volunteers
- 144 people
- Sponsor
- Takeda
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.
Dravet Syndrome
A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome
This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with…
- Trial name
- ARGUS (NCT04462770)
- Testing
- Clemizole HCl
- Where
- 68 sites in United States, Argentina and 8 more
- Volunteers
- 150 people
- Sponsor
- Epygenix
Dravet Syndrome, Lennox Gastaut Syndrome
Intermediate-Size Expanded Access Protocol (EAP) for LP352
This is an intermediate-size expanded access program (EAP) study. The purpose of this EAP is to provide continued access to LP352, an investigational drug product being investigated in participants with DEEs.
- Conditions
- Dravet Syndrome, Lennox Gastaut Syndrome, Developmental and Epileptic Encephalopathies
- Trial name
- NCT06149663
- Testing
- LP352
- Where
- 22 sites in United States, Australia
- Sponsor
- Longboard Pharmaceuticals
Dravet Syndrome, Epilepsy
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
This is a Phase I, open-label, randomized, single-center, two-way cross-over study evaluating the relative bioavailability, pharmacokinetics, safety, and palatability of two formulations of stiripentol (Diacomit®), indicated in…
- Conditions
- Dravet Syndrome, Epilepsy, Childhood, Epileptic Encephalopathy
- Trial name
- STILIQ (NCT07176832)
- Testing
- Stiripentol capsule (Diacomit®), Stiripentol oral suspension (Diacomit®)
- Where
- 2 sites in France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Biocodex
Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)
A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS).
- Trial name
- NCT05163314
- Testing
- Soticlestat
- Where
- 116 sites in United States, Australia and 18 more
- Volunteers
- 352 people
- Sponsor
- Takeda
Dravet Syndrome
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome
The purpose of this study is to investigate the effect on the frequency of tonic-clonic and clonic seizures of clobazam as adjunctive therapy compared to placebo after 16 weeks of treatment in paediatric patients aged ≥1 to ≤16…
- Trial name
- NCT02174094
- Testing
- Clobazam
- Where
- 9 sites in United States, Mexico
- Sponsor
- H. Lundbeck A/S
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain
The main aims of this study are to gather information about how many children, teenagers and adults in Spain have been diagnosed with Dravet syndrome and Lennox-Gastaut syndrome as well as to learn about the number of new Dravet…
- Trial name
- DRALEGA (NCT05982717)
- Testing
- No intervention
- Where
- 4 sites in Spain
- Volunteers
- 237 people
- Sponsor
- Takeda
Epilepsy, Dravet Syndrome (DS)
A Study of Soticlestat in Adults and Children With Rare Epilepsies
The main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment. Participants will receive soticlestat twice a day.
- Conditions
- Epilepsy, Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
- Trial name
- Endymion 1 (NCT03635073)
- Testing
- Soticlestat
- Where
- 59 sites in United States, Australia and 6 more
- Volunteers
- 156 people
- Sponsor
- Takeda
Seizures
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including…
- Trial name
- NCT02318602
- Testing
- Cannabidiol Oral Solution
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- INSYS Therapeutics Inc
Absence Epilepsy, Jeavons Syndrome
BMB-101 in Absence Epilepsy and DEE
The study is a pilot, open-label, study to test whether BMB-101 is safe and effective in reducing the frequency of seizures in subjects with Absence Epilepsy including Epilepsy with Eyelid Myoclonia (also called Jeavons Syndrome)…
- Conditions
- Absence Epilepsy, Jeavons Syndrome, Dravet Syndrome, Lennox Gastaut Syndrome
- Trial name
- NCT06401538
- Testing
- BMB-101
- Where
- 5 sites in Australia
- Volunteers
- 20 people
- Sponsor
- Bright Minds Biosciences Pty Ltd
Dravet Syndrome (DS), Lennox-Gastaut Syndrome (LGS)
A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal
The main aim of this study is to learn about the percentage of persons diagnosed with Dravet Syndrome (DS) and Lennox-Gastaut-Syndrome (LGS) in 2022 and of persons newly diagnosed in 2021 and 2022 compared to the overall…
- Trial name
- DRALEGA-PT (NCT06395792)
- Testing
- No Intervention
- Sponsor
- Takeda