An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome
This study has been terminated.
(all active subjects rolled into 209FX303/NCT01013480)
Sponsor:
Seaside Therapeutics, Inc.
Information provided by (Responsible Party):
Seaside Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01013480
First received: November 12, 2009
Last updated: December 19, 2012
Last verified: March 2011
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Purpose
Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care.
| Condition | Intervention | Phase |
|---|---|---|
|
Fragile X Syndrome |
Drug: Arbaclofen |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
fragile X syndrome
MECP2 duplication syndrome
PPM-X syndrome
Renpenning syndrome
tetrasomy 18p
MedlinePlus related topics:
Fragile X Syndrome
U.S. FDA Resources
Further study details as provided by Seaside Therapeutics, Inc.:
Primary Outcome Measures:
- Irritability subscale of the Aberrant Behavior Checklist [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | November 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: STX209 |
Drug: Arbaclofen
A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID
Other Names:
|
Eligibility| Ages Eligible for Study: | 6 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator
Exclusion Criteria:
- Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
- The occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01013480
Locations
| United States, California | |
| University of California-Los Angeles Neuropsychiatric Institute | |
| Los Angeles, California, United States, 90024 | |
| M.I.N.D. Institute | |
| Sacramento, California, United States, 95817 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, New York | |
| NYS Institute for Basic Research in Developmental Disabilities | |
| Staten Island, New York, United States, 10314 | |
| United States, North Carolina | |
| University of North Carolina Neurosciences Hospital | |
| Chapel Hill, North Carolina, United States, 27514 | |
| United States, Pennsylvania | |
| Suburban Research Associates | |
| Media, Pennsylvania, United States, 19063 | |
| United States, Tennessee | |
| Vanderbilt Kennedy Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Red Oaks Psychiatry Associates, PA | |
| Houston, Texas, United States, 77090 | |
| United States, Washington | |
| Seattle Children's Hospital | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Seaside Therapeutics, Inc.
More Information
No publications provided
| Responsible Party: | Seaside Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01013480 History of Changes |
| Other Study ID Numbers: | 22002 |
| Study First Received: | November 12, 2009 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seaside Therapeutics, Inc.:
|
Fragile X Syndrome |
Additional relevant MeSH terms:
|
Fragile X Syndrome Mental Retardation, X-Linked Mental Retardation 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 |
ClinicalTrials.gov processed this record on May 19, 2013