Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01282268
• Date of registration: 20/01/2011
• Prospective Registration: Yes
• Primary sponsor: Seaside Therapeutics, Inc.
• Public title: Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome Harbor-A
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome
• Date of first enrolment: May 2011
• Target sample size: 125
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01282268
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Paul Wang, M.D.
• Affiliation: Seaside Therapeutics, Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 12 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Fragile X Syndrome

Intervention(s)

Drug: arbaclofen

Drug: placebo

Primary Outcome(s)

Aberrant Behavior Checklist - FXS Social Avoidance Subscale [Time Frame: At 8 weeks of treatment]

Secondary ID(s)

209FX301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors