Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome
NCT00065923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2013-05-01
Summary
Prader-Willi syndrome (PWS) is a genetic disorder usually caused by the deletion of a specific gene. One of the symptoms of PWS is self-injurious behavior (SIB); a common form of SIB in PWS patients is skin picking. The injury may be severe enough to require frequent medical attention. This trial will evaluate SIB in individuals with PWS and will test the effectiveness of the drug topiramate to control SIB.
Conditions
- Prader-Willi Syndrome
- Self-Injurious Behavior
Interventions
- DRUG
-
Topiramate
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
lead NIH
Principal Investigators
-
Nathan A. Shapira, MD, PhD · University of Florida
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 66 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2002-07-31
- Primary Completion
- 2005-12-31
Countries
- United States
Study Locations
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