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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.

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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

Fragile X Syndrome

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

FieldValue
Enrollment Target 125 participants
Start Date 2011-05
Phase Phase 3

Sponsor

Seaside Therapeutics

12 total trials

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What the Registry Record Tells You About NCT01282268

The ClinicalTrials.gov registry entry for NCT01282268 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 94-participant average among 16 other Fragile X Syndrome trials with a reported enrollment target (33% higher). The listed sponsor is Seaside Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 16 distinct geographic areas - top geographies include 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.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.