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NCT01282268 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome
A Phase 3 study of Fragile X Syndrome, sponsored by Seaside Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 125
- Enrollment target
- 20
- Study locations
NCT01282268: Completed Phase 3 study of Fragile X Syndrome, sponsored by Seaside Therapeutics.
NCT01282268 is a Phase 3 study of Fragile X Syndrome that has completed, run by Seaside Therapeutics. The registered enrollment target is 125 participants, above the 94-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01282268, a Phase 3 study of Fragile X Syndrome, has completed, sponsored by Seaside Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 125 participants
- Enrollment target
- 20
- Study locations
Study Summary
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)
Conditions Studied
Interventions
- DRUG placebo
- DRUG arbaclofen
Study Locations (20)
California
- Miller Children's Hospital Research Administration - Long Beach
- University of California-Davis, M.I.N.D. Institute - Sacramento
- Psychiatric Centers at San Diego - San Diego
Florida
- University of Miami, Mailman Center for Child Development - Miami
- Lake Mary Pediatrics - Orange City
New York
- Seaver Autism Center, Mount Sinai Medical Center - New York
- New York State Institute for Basic Research in Developmental Disabilities - Staten Island
Arizona
- Southwest Autism Research & Resource Center - Phoenix
Colorado
- University of Colorado Denver, Children's Hospital - Aurora
Georgia
- Emory University School of Medicine - Decatur
Illinois
- Rush University Medical Center - Chicago
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2011-05 |
| Phase | Phase 3 |
What the finished NCT01282268 record still lists
NCT01282268 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, above the 94-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Fragile X Syndrome appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01282268 names 20 study sites across 16 states, led by California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT01282268 about?
NCT01282268 is a clinical study titled "Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome". To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)
What is the current status of trial NCT01282268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 125 participants. The study started on 2011-05.
What conditions does trial NCT01282268 study?
This clinical trial studies the following conditions: Fragile X Syndrome.
What interventions are being tested in trial NCT01282268?
The interventions under investigation include: placebo (DRUG), arbaclofen (DRUG).
Who is sponsoring clinical trial NCT01282268?
This trial is sponsored by Seaside Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01282268 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fragile X Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01282268's enrollment target sits among peer trials
125 4th of 16 higher than 13 of 16 other Fragile X Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fragile X Syndrome 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
-
An Open-Label Extension Study of BPN14770 in Subjects With Fragile X Syndrome
ACTIVE NOT RECRUITING · Phase 3
-
Physical Activity and Community EmPOWERment Project
RECRUITING · NA
-
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG- Infant
RECRUITING · NA
-
Web Intervention for Parents of Youth With Genetic Syndromes (WINGS)
RECRUITING · NA
-
Tracking Early Emergence of Sound Perception Impairments in FXS With Multimodal fNIRS/EEG-Preschool Age
RECRUITING · NA
-
Speech-in-noise Perception in Autism and Fragile X
RECRUITING · NA
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