MedTrace Logo

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

NCT01325220 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2013-07-31

No results posted yet for this study

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

Conditions

  • Fragile X Syndrome

Interventions

DRUG

arbaclofen

5 mg bid

DRUG

arbaclofen

10 mg bid

DRUG

arbaclofen

10 mg tid

DRUG

Placebo

tid

Sponsors & Collaborators

  • Seaside Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Wang, M.D. · Seaside Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01325220 on ClinicalTrials.gov