Open Label Extension Study of STX209 (Arbaclofen) in Autism Spectrum Disorders

NCT01706523 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2013-07-31

No results posted yet for this study

Summary

This is an open-label extension protocol that will provide necessary data on the safety, tolerability, pharmacokinetics and efficacy of STX209 among subjects with ASD.

Conditions

  • Autism Spectrum Disorders

Interventions

DRUG

STX209 (arbaclofen)

Long-term, daily, orally-administered STX209

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
21 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 NCT01706523 on ClinicalTrials.gov