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An Open Label Extension Study in Subjects With Fragile X Syndrome

NCT01555333 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2013-07-31

No results posted yet for this study

Summary

This study will enroll subjects who have completed Protocols 209FX301, 209FX302, or are currently participating in Protocol 2202 into a long-term study in which all subjects will receive active drug (arbaclofen).

Conditions

  • Fragile X Syndrome

Interventions

DRUG

arbaclofen

A flexible dose titration will be utilized. Orally disintegrating tablets

Sponsors & Collaborators

  • Seaside Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • United States

Study Locations

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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 NCT01555333 on ClinicalTrials.gov