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CDKL5 Deficiency Disorder clinical trials

View clinical trials related to CDKL5 Deficiency Disorder.

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NCT ID: NCT05558371 Recruiting - Clinical trials for CDKL5 Deficiency Disorder

International CDKL5 Clinical Research Network

ICCRN
Start date: February 15, 2021
Phase:
Study type: Observational

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 and cortical visual impairment. While capability for disease modifying therapies is accelerating, there is a critical barrier for clinical trial readiness that may result in failure of these therapies, not due to lack of efficacy but due to lack of validated outcome measures and biomarkers. The measures and biomarkers validated here will be adaptable to other developmental and epileptic encephalopathies.

NCT ID: NCT05249556 Not yet recruiting - Clinical trials for CDKL5 Deficiency Disorder

Double-blind, Randomized, Placebo-controlled Trial of Ganaxolone in CDKL5 Deficiency Patients 6 Months to Less Than 2 Years Old

Start date: July 2024
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of ganaxolone (GNX) compared with placebo (PBO) as adjunctive therapy to the participant's standard anti-epileptic medication for the treatment of seizures in pediatric patients from 6 months to less than 2 years old with genetically confirmed CDD during a 12-week, DB phase. Pharmacokinetic (PK) assessments and population PK analyses will also be performed during this time. The DB phase will be followed by an optional long-term OL phase at which time all participants will receive GNX as an adjunct to their standard anti-seizure medication. Efficacy, safety and tolerability, and PK assessments will continue to be performed.

NCT ID: NCT05064878 Recruiting - Clinical trials for CDKL5 Deficiency Disorder

A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder

Start date: March 8, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, double-blind, parallel-group, placebo controlled, 2-part study to evaluate the efficacy and safety of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with cyclin-dependent kinase like-5 (CDKL5) deficiency disorder (CDD).

NCT ID: NCT03572933 Completed - Clinical trials for CDKL5 Deficiency Disorder

Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder

Marigold
Start date: June 30, 2018
Phase: Phase 3
Study type: Interventional

A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone therapy compared to placebo for the treatment of seizures in children and young adults with genetically confirmed CDKL5 gene mutation.