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

NCT00065923 | Completed

• 1 other identifier: R03HD042818
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prader-Willi Syndrome; Self-Injurious Behavior

Interventions

Topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (1)

University of Florida-Brain Institute

Gainesville, Florida, 32609, United States

Location

Related Links

• Primary family support organization for Prader-Willi Syndrome

MeSH Terms

Conditions

Prader-Willi Syndrome; Self-Injurious Behavior

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Nathan A. Shapira, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 1, 2003
• First Posted: August 5, 2003
• Study Start: July 1, 2002
• Primary Completion: December 1, 2005
• Last Updated: May 1, 2013

Record last verified: 2010-08

Locations

US (1)