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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). 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
Primary Outcome
This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal
Interventions
- DRUG Placebo
- DRUG arbaclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2011-06 |
| Phase | Phase 3 |
What the finished NCT01325220 record still lists
NCT01325220 is an interventional study that assigns participants to a tested intervention. The registered 172 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 (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01325220 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01325220's enrollment target sits among peer trials
172 1448th of 2000 higher than 550 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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