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NCT01325220 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome
A Phase 3 study, sponsored by Seaside Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
NCT01325220: Completed Phase 3 study, sponsored by Seaside Therapeutics.
NCT01325220 is a Phase 3 study that has completed, run by Seaside Therapeutics. The registered enrollment target is 172 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01325220, a Phase 3 study, has completed, sponsored by Seaside Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
Study Summary
There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically
Interventions
- DRUG Placebo
- DRUG arbaclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2011-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01325220
The ClinicalTrials.gov registry entry for NCT01325220 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seaside Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01325220 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01325220 about?
NCT01325220 is a clinical study titled "Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome". There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) ...
What is the current status of trial NCT01325220?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2011-06.
What interventions are being tested in trial NCT01325220?
The interventions under investigation include: Placebo (DRUG), arbaclofen (DRUG).
Who is sponsoring clinical trial NCT01325220?
This trial is sponsored by Seaside Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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