Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01013480
The ClinicalTrials.gov registry entry for NCT01013480 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 45 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 1 intervention - of which Arbaclofen is the first listed.
NCT01013480 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.