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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 is a Phase 2 study that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 57 participants.
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.
Interventions
- OTHER Placebo
- DRUG Ganaxolone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00441896
The ClinicalTrials.gov registry entry for NCT00441896 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Marinus Pharmaceuticals, which has 19 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00441896 reports 0 study locations.
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.
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