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NCT01013480 · ClinicalTrials.gov registry record · Phase 2
An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
A Phase 2 study, sponsored by Seaside Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01013480: Clinical Trial Phase 2 study, sponsored by Seaside Therapeutics.
NCT01013480 is a Phase 2 study that was terminated before completion, run by Seaside Therapeutics. The registered enrollment target is 45 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01013480, a Phase 2 study, was terminated before completion, sponsored by Seaside Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care.
Interventions
- DRUG Arbaclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
Why NCT01013480 stopped before completion
NCT01013480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Arbaclofen is the first listed.
NCT01013480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01013480 about?
NCT01013480 is a clinical study titled "An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome". Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors...
What is the current status of trial NCT01013480?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2009-11. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01013480?
The interventions under investigation include: Arbaclofen (DRUG).
Who is sponsoring clinical trial NCT01013480?
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 NCT01013480's enrollment target sits among peer trials
45 1296th of 2000 higher than 679 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
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