Efficacy and Safety Study of STX209 (Arbaclofen) for Social Withdrawal in Adolescents and Adults With Fragile X Syndrome (Harbor-A)
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| ClinicalTrials.gov Identifier: NCT01282268 |
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Recruitment Status :
Completed
First Posted : January 24, 2011
Last Update Posted : July 31, 2013
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Sponsor:
Seaside Therapeutics, Inc.
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
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Brief Summary:
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)
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fragile X Syndrome | Drug: arbaclofen Drug: placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 125 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of STX209 (Arbaclofen) Administered for the Treatment of Social Function in Adolescents and Adults With Fragile X Syndrome |
| Study Start Date : | May 2011 |
| Actual Primary Completion Date : | December 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Fragile X syndrome
MedlinePlus related topics:
Fragile X Syndrome
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: Arbaclofen |
Drug: arbaclofen
orally disintegrating tablet
Other Name: STX209 |
| Placebo Comparator: Placebo |
Drug: placebo
orally disintegrating tablet |
Primary Outcome Measures :
- Aberrant Behavior Checklist - FXS Social Avoidance Subscale [ Time Frame: At 8 weeks of treatment ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 12 Years to 50 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282268
Locations
Show 24 study locations
Sponsors and Collaborators
Seaside Therapeutics, Inc.
Investigators
| Study Director: | Paul Wang, M.D. | Seaside Therapeutics, Inc. |
| Responsible Party: | Seaside Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01282268 |
| Other Study ID Numbers: |
209FX301 |
| First Posted: | January 24, 2011 Key Record Dates |
| Last Update Posted: | July 31, 2013 |
| Last Verified: | July 2013 |
Keywords provided by Seaside Therapeutics, Inc.:
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fragile X syndrome autism spectrum disorder |
Additional relevant MeSH terms:
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Fragile X Syndrome Syndrome Disease Pathologic Processes Mental Retardation, X-Linked Intellectual Disability Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Sex Chromosome Disorders Chromosome Disorders Congenital Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Heredodegenerative Disorders, Nervous System |