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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00788073 |
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Date of registration:
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07/11/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
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Scientific title:
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A Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00788073 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Randi Hagerman, MD |
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Affiliation:
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M.I.N.D. Institute |
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Name:
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Linmarie Sikich, MD |
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Affiliation:
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University of North Carolina Neurosciences Hospital |
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Name:
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Craig Erikson, MD |
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Address:
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Affiliation:
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Riley Hospital for Children |
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Name:
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Ted Brown, MD, PhD |
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Address:
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Affiliation:
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NYS institute for Basic Research in Developmental Disabilities |
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Name:
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Raun Melmed, MD |
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Address:
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Affiliation:
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Southwest Autism Research & Resource Center |
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Name:
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James McCracken, MD |
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Address:
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Affiliation:
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University of California, Los Angeles |
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Name:
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Elizabeth Berry-Kravis, MD, PhD |
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Affiliation:
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Rush University Medical Center |
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Name:
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Jonathan Picker, MBChB, PhD |
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Address:
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Affiliation:
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Boston Children’s Hospital |
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Name:
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Jeremy Veenstra-VanderWeele, MD |
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Address:
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Affiliation:
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Vanderbilt Kennedy Center |
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Name:
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Lawrence Ginsberg, MD |
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Affiliation:
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Red Oaks Psychiatry Associates, PA |
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Name:
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Bryan King, MD, PhD |
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Address:
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Affiliation:
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Seattle Children's Hospital |
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Name:
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Shivkumar Hatti, MD |
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Affiliation:
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Suburban Research Associates |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age
- Molecular documentation of the fragile X mutation.
- Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate
or higher at screening and at Visit 1
- An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score >12 and at least 3
items on the Irritability Subscale rated at least moderate or above.
- Current treatment with no more than three psychoactive medications, including
anti-epileptics.
- Current pharmacological treatment regimen has been stable for at least 4 weeks.
Exclusion Criteria:
- Subjects with a history of seizure disorder who are not currently receiving treatment
with antiepileptics.
- 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. This includes, but is not limited to impairment of
renal function, evidence or history of malignancy or any significant hematological,
endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.
- Subjects who plan to initiate or change pharmacologic or non-pharmacologic
interventions during the course of the study.
- Subjects who are currently receiving treatment with racemic baclofen.
- Subjects currently treated with vigabatrin or tiagabine.
- Subjects taking another investigational drug currently or within the last 30 days.
Age minimum:
6 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Fragile X Syndrome
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Intervention(s)
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Drug: Placebo
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Drug: STX209
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Primary Outcome(s)
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Aberrant Behavior Checklist Irritability Subscore
[Time Frame: After 4 weeks of treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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