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NCT03572933 · ClinicalTrials.gov registry record · Phase 3
Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder
A Phase 3 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 101
- Enrollment target
NCT03572933: Completed Phase 3 study, sponsored by Marinus Pharmaceuticals.
NCT03572933 is a Phase 3 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 101 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03572933, a Phase 3 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 101 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Summary of 28-day seizure frequency for Major Motor Seizure Types during the double-blind treatment period relative to the 6-week prospective baseline period Note: Summaries are based on the sum of the individual seizures, the countable seizures, and the clusters with uncountable seizures (each cluster with uncountable seizures counts as 1 seizure). Within the baseline and post baseline intervals, 28-day seizure frequency was calculated as the total number of seizures in the interval divided by
Interventions
- DRUG Placebo
- DRUG ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2018-06-30 |
| Est. Completion | 2021-05-28 |
| Phase | Phase 3 |
What the finished NCT03572933 record still lists
NCT03572933 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03572933 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03572933 about?
NCT03572933 is a clinical study titled "Study of Adjunctive Ganaxolone Treatment in Children and Young Adults With CDKL5 Deficiency Disorder". 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.
What is the current status of trial NCT03572933?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 101 participants. The study started on 2018-06-30. Estimated completion is 2021-05-28.
What interventions are being tested in trial NCT03572933?
The interventions under investigation include: Placebo (DRUG), ganaxolone (DRUG).
Who is sponsoring clinical trial NCT03572933?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03572933's enrollment target sits among peer trials
101 1680th of 2000 higher than 320 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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