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Main
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Note: This record shows only the 20 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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6 May 2013 |
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Main ID: |
NCT00065923 |
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Date of registration:
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01/08/2003 |
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Primary sponsor: |
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Public title:
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Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome
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Scientific title:
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Topiramate Effects on SIB in Prader-Willi Syndrome |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00065923 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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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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Nathan A. Shapira, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- PWS due to deletion of 15 q11-13 or uniparental disomy
- Actively engaging skin picking behavior
- Individual with PWS or legal guardian able to provide full informed consent. If
legal guardian gives informed consent, then individual with PWS will give his/her
assent.
- Acceptable methods of contraception
Exclusion Criteria
- Pregnant or breastfeeding
- Clinically significant suicidality or homicidality
- DSM-IV diagnosis of substance abuse or dependence within 6 months of study entry
- Cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or
other systemic disease which could interfere with treatment or assessment of PWS
- Treatment with any drug which might interact adversely with topiramate
- Medication or significant behavioral management change within 4 weeks of study entry
- Personal history or a first-degree family history of nephrolithiasis
Age minimum:
18 Years
Age maximum:
66 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prader-Willi Syndrome
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Self-Injurious Behavior
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Intervention(s)
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Drug: Topiramate
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Secondary ID(s)
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R03HD42818
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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