Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00441896 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms
A Phase 2 study, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT00441896: Completed Phase 2 study, sponsored by Marinus Pharmaceuticals.
NCT00441896 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00441896, a Phase 2 study, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study Summary
The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive ascending doses of placebo and ascending doses of ganaxolone. The dosing level in each subsequent cohort will be based upon experience gained from previous cohorts.
Primary Outcome
Spasm clusters were determined by a 24-hour video-electroencephalography (vEEG) at Day 10. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the Day 0 assessment before study drug infusion.
Interventions
- OTHER Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
What the finished NCT00441896 record still lists
NCT00441896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00441896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00441896 about?
NCT00441896 is a clinical study titled "A Randomized, Controlled Trial of Ganaxolone in Patients With Infantile Spasms". The study consists of cohorts where participants are randomized, in a 2:1 ratio, to 1 of 2 sequences, A and B. In each cohort, Sequence A, comprised of participants, who will receive ascending doses of ganaxolone and ascending doses of placebo. Sequence B, comprised of participants, who will receive...
What is the current status of trial NCT00441896?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2007-01. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00441896?
The interventions under investigation include: Placebo (OTHER), Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT00441896?
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 NCT00441896's enrollment target sits among peer trials
57 1141st of 2000 higher than 855 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03521830 · 57 participants · Phase 2
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
- NCT03587701 · 57 participants · Phase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
- NCT04104126 · 57 participants · NA
Blood Flow Restriction Therapy in Achilles Injury
- NCT04703842 · 57 participants · Phase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia