Trial record 4 of 7 for:    stx209 and fragile x syndrome

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01325220
First received: March 28, 2011
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Fragile X Syndrome
Drug: arbaclofen
Drug: Placebo
Phase 3

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
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Children With Fragile X Syndrome

Resource links provided by NLM:


Further study details as provided by Seaside Therapeutics, Inc.:

Primary Outcome Measures:
  • Aberrant Behavior Checklist-Lethargy Social Withdrawal subscale [ Time Frame: at 8 weeks of treatment ] [ Designated as safety issue: No ]
    This is a single subscale of the aberrant behavior checklist entitiled Lethargy Social Withdrawal


Enrollment: 172
Study Start Date: June 2011
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: STX209 5 mg BID Drug: arbaclofen
5 mg bid
Other Name: R-baclofen, STX209
Active Comparator: STX209 10 mg BID Drug: arbaclofen
10 mg bid
Other Name: R-baclofen, STX209
Active Comparator: STX209 10 mg TID Drug: arbaclofen
10 mg tid
Other Name: R-baclofen, STX209
Placebo Comparator: Placebo Drug: Placebo
tid

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325220

  Show 28 Study Locations
Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
Study Director: Paul Wang, M.D. Seaside Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01325220     History of Changes
Other Study ID Numbers: 209FX302
Study First Received: March 28, 2011
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fragile X Syndrome
Syndrome
Mental Retardation, X-Linked
Genetic Diseases, X-Linked
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014