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NCT02358538 · ClinicalTrials.gov registry record · Phase 2
Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies
A Phase 2 study of Epilepsy, sponsored by Marinus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 10
- Study locations
NCT02358538: Completed Phase 2 study of Epilepsy, sponsored by Marinus Pharmaceuticals.
NCT02358538 is a Phase 2 study of Epilepsy that has completed, run by Marinus Pharmaceuticals. The registered enrollment target is 30 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02358538, a Phase 2 study of Epilepsy, has completed, sponsored by Marinus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 10
- Study locations
Study Summary
To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
Primary Outcome
Percentage change from baseline in 28-day seizure frequency at 3 months (day 91), 26 weeks, 52 week OLE (Mean Percent Change \& Standard Deviation)
Conditions Studied
Interventions
- DRUG Ganaxolone
Study Locations (10)
California
- Sutter Institute for Medical Research - Sacramento
- University of California San Francisco - San Francisco
New Jersey
- Northeast Regional Epilepsy Group - Hackensack
- Institute of Neurology and Neurosurgery at St. Barnabas - Livingston
Arizona
- Phoenix Children's Hospital - Phoenix
Georgia
- Center for Rare Neurological Diseases - Norcross
Indiana
- JWM Neurology - Indianapolis
Massachusetts
- Boston Children's Hospital - Boston
Ohio
- Nationwide Children's Hospital - Columbus
Other
- Bambino Gesu Children's Hospital, IRCCS - Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-11-06 |
| Est. Completion | 2019-01-04 |
| Phase | Phase 2 |
What the finished NCT02358538 record still lists
NCT02358538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Ganaxolone is the first listed.
NCT02358538 lists 10 locations in 8 states (California, New Jersey, Arizona).
Frequently Asked Questions
What is clinical trial NCT02358538 about?
NCT02358538 is a clinical study titled "Open-Label PoC Trial of Ganaxolone in Children With PCDH19 Female Pediatric Epilepsy and Other Rare Genetic Epilepsies". To evaluate the efficacy of open-label ganaxolone as adjunctive therapy for uncontrolled seizures in female children with PCDH19 mutation and other rare genetic epilepsies in an open-label proof-of-concept study.
What is the current status of trial NCT02358538?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-11-06. Estimated completion is 2019-01-04.
What conditions does trial NCT02358538 study?
This clinical trial studies the following conditions: Epilepsy.
What interventions are being tested in trial NCT02358538?
The interventions under investigation include: Ganaxolone (DRUG).
Who is sponsoring clinical trial NCT02358538?
This trial is sponsored by Marinus Pharmaceuticals, which has 19 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02358538 being conducted?
This trial has 10 study locations across Arizona, California, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02358538's enrollment target sits among peer trials
30 109th of 160 higher than 41 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy 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.
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