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

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 2 months later Sep 2028 → Dec 2029
See other at-risk trials from Immedica Pharma AB

Record History

  1. Primary and study completion pushed from Sep 2028 to Dec 2029
    • Start date: Jun 2026 to Mar 2027
    v7
  2. Lead sponsor: Marinus Pharmaceuticals to Immedica Pharma ABv6
  3. Primary completion date: Dec 2026 to Sep 2028
    • Start date: Dec 2024 to Jun 2026
    • Study completion date: Mar 2027 to Sep 2028
    v5
  4. Primary completion date: Dec 2024 to Dec 2026
    • Start date: Jul 2024 to Dec 2024
    • Study completion date: Dec 2024 to Mar 2027
    v4
  5. Start date: May 2023 to Jul 2024v3
  6. Primary and study completion dates: Oct 2023 to Dec 2024
    • Start date: Apr 2022 to May 2023
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05249556
Lead Sponsor Immedica Pharma AB
Conditions
(from sponsor)		 CDKL5 Deficiency Disorder
Related terms CDKL5 deficiency disorder
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov