Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

Phase 3

Completed

• Conditions: Fragile X Syndrome
• Interventions: Drug: Placebo; Drug: arbaclofen

• Registration Number: NCT01325220
• Lead Sponsor: Seaside Therapeutics, Inc.

Brief Summary

There will be four study periods: Screening (up to 14 days in length), the Treatment Period (8 weeks), the Withdrawal Period (22 days), and Follow-up Period (up to 31 days). Subjects will be randomized to receive either STX209 (5 mg twice daily \[BID\], 10 mg BID or 10 mg three times daily \[TID\]) or placebo. Efficacy,safety and tolerability assessments will be performed periodically

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Study Start: 2011-06
• Primary Completion: 2013-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-30
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Molecular documentation of the full FMR1 mutation
• Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening.
• Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics.
• If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening

Exclusion Criteria

• Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
• Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
• Subjects who have taken another investigational drug within the last 30 days.
• Subjects who are not able to take oral medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
STX209 10 mg BID	arbaclofen	-
STX209 5 mg BID	arbaclofen	-
STX209 10 mg TID	arbaclofen	-

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale	at 8 weeks of treatment	This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal

Trial Locations

Locations (28)

Southwest Autism Research & Resource Center; 🇺🇸 Phoenix, Arizona, United States

Miller Children's Hospital; 🇺🇸 Long Beach, California, United States

University of California-Davis, M.I.N.D. Institute; 🇺🇸 Sacramento, California, United States

Psychiatric Centers at San Diego; 🇺🇸 San Diego, California, United States

University of Colorado Denver, Children's Hospital; 🇺🇸 Aurora, Colorado, United States

University of Miami, Mailman Center for Child Development; 🇺🇸 Miami, Florida, United States

Lake Mary Pediatrics; 🇺🇸 Orange City, Florida, United States

Emory University School of Medicine; 🇺🇸 Decatur, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Kansas University Clinical Research Center; 🇺🇸 Fairway, Kansas, United States

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