Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower). 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 |
Why NCT01064973 stopped before completion
NCT01064973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which arbaclofen is the first listed.
NCT01064973 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01064973's enrollment target sits among peer trials
32 1563rd of 2000 higher than 423 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02445781 · 32 participants · Early Phase 1
Differing Levels of Hypoglycemia
- NCT02792270 · 32 participants · NA
Caloric Restriction In Sarcoma Patients Treated With Pre-Operative RT
- NCT03068910 · 32 participants · Early Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
- NCT03208868 · 32 participants · NA
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia