Clinical trials: Cyclin-Dependent Kinase-Like 5 Deficiency Disorder
CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure
A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.
This is a Phase 3 Study to examine the efficacy and safety of ZX008 in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).
- Conditions
- CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure, Epileptic Spasm, Refractory Seizures
- Trial name
- GEMZ (NCT05064878)
- Testing
- Fenfluramine
- Where
- 46 sites in United States, Austria and 12 more
- Volunteers
- 87 people
- Sponsor
- Zogenix, Inc.
CDKL5 Deficiency Disorder
Efficacy and Safety of Daily Home-based Hyperthermic Baths for Reducing Epileptic Seizures in CDKL5 Deficiency Disorder: A PROBE Clinical Trial
The primary objective of this research is to study the efficacy and safety of daily, home-based hyperthermic baths for reducing epileptic seizures in CDKL5 Deficiency Disorder.
- Trial name
- NCT07602205
- Testing
- Home-based hyperthermic Baths
- Volunteers
- 34 people
- Sponsor
- Xuanwu Hospital, Beijing
15q Duplication Syndrome, CDKL5 Deficiency Disease
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
- Trial name
- NCT03694275
- Testing
- Soticlestat
- Where
- 8 sites in United States
- Volunteers
- 20 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
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
CDKL5
Targeting the Gut to Improve Seizure Control in CDKL5 Deficiency Disorder (CDD)
Standard anti-seizure medications have limited efficacy in seizure control in cyclin-dependent kinase-like 5 deficiency disorder (CDD).
- Trial name
- NUTRIENT (NCT06448663)
- Testing
- alpha-lactalbumin, fructooligosaccharides, inulin, alpha-lactalbumin, sodium butyrate, fructooligosaccharides, inulin
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- University of Milan
CDKL5, CDKL5 Deficiency Disorder
International CDKL5 Clinical Research Network
Pathogenic variants in the Cyclin-dependent kinase like 5 (CDKL5) gene cause CDKL5 deficiency disorder (CDD, MIM 300672, 105830), a severe developmental and epileptic encephalopathy associated with cognitive and motor impairments…
- Conditions
- CDKL5, CDKL5 Deficiency Disorder, CDD
- Trial name
- ICCRN (NCT05558371)
- Testing
- No intervention.
- Where
- 9 sites in United States, Australia
- Volunteers
- 1,000 people
- Sponsor
- University of Colorado, Denver