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

Seaside Therapeutics

Status and phase

Completed

Phase 3

Conditions

Fragile X Syndrome

Treatments

Drug: placebo

Drug: arbaclofen

Study type

Interventional

Funder types

Industry

Identifiers

NCT01282268

209FX301

Details and patient eligibility

About

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)

Enrollment

125 patients

Sex

All

Ages

12 to 50 years old

Volunteers

No Healthy Volunteers

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.