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NCT01064973 · ClinicalTrials.gov registry record · Phase 2
An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders
A Phase 2 study, sponsored by Seaside Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
NCT01064973: Clinical Trial Phase 2 study, sponsored by Seaside Therapeutics.
NCT01064973 is a Phase 2 study that was terminated before completion, run by Seaside Therapeutics. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01064973, a Phase 2 study, was terminated before completion, sponsored by Seaside Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
Study Summary
Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with ASD. This study (22007) will enter subjects who complete Study 22003 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 ASD who receive treatment under conditions more closely reflective of their general medical care.
Interventions
- DRUG arbaclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01064973
The ClinicalTrials.gov registry entry for NCT01064973 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 32 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.
NCT01064973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01064973 about?
NCT01064973 is a clinical study titled "An Open Label Extension Study of STX209 in Subjects With Autism Spectrum Disorders". Study 22003, "An Open-Label, Flexible-Dose Evaluation of the Safety and Tolerability of STX209 for Treatment of Irritability in Subjects With Autism Spectrum Disorders(ASD)" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability ...
What is the current status of trial NCT01064973?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2010-02. Estimated completion is 2012-12.
What interventions are being tested in trial NCT01064973?
The interventions under investigation include: arbaclofen (DRUG).
Who is sponsoring clinical trial NCT01064973?
This trial is sponsored by Seaside Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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