Treatment of Self-Injurious Behavior in Individuals With Prader-Willi Syndrome

Completed · Not applicable

Conditions studied: Prader-Willi Syndrome, Self-Injurious Behavior

In brief

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.

Key facts

Study ID

NCT00065923

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

10

Starts

2002-07-01

Last updated by the study team

2013-05-01

Who can join

Age: 18 and older, up to 66. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Florida-Brain Institute — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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