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NCT00788073 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
A Phase 2 study, sponsored by Seaside Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 63
- Enrollment target
NCT00788073: Completed Phase 2 study, sponsored by Seaside Therapeutics.
NCT00788073 is a Phase 2 study that has completed, run by Seaside Therapeutics. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00788073, a Phase 2 study, has completed, sponsored by Seaside Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 63 participants
- Enrollment target
Study Summary
The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be safe and well tolerated.
Primary Outcome
The Aberrant Behavior Checklist-Community Edition (ABC-C) is a 58-item questionnaire composed of five different independent subscales. The questionnaire is completed by the parent/caregiver and lists aberrant behaviors and asks about the severity of the problem. ABC-Irritability is one of the subscales and comprises of 15 items. Minimum score is 0, maximum is 45. A decreased score indicates few aberrant behaviors and clinical improvement. The entire ABC-C assessment is administered at baseline a
Interventions
- DRUG Placebo
- DRUG STX209
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2008-11 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
What the finished NCT00788073 record still lists
NCT00788073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00788073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00788073 about?
NCT00788073 is a clinical study titled "Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome". The study objective is to explore the efficacy, safety and tolerability of STX209 for treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve irritability and other typical problem behaviors associated with fragile X syndrome. We also hypothesize that STX209 will be s...
What is the current status of trial NCT00788073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2008-11. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00788073?
The interventions under investigation include: Placebo (DRUG), STX209 (DRUG).
Who is sponsoring clinical trial NCT00788073?
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 NCT00788073's enrollment target sits among peer trials
63 1009th of 2000 higher than 985 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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