Status:
COMPLETED
Dietary Supplements for the Treatment of Angelman Syndrome
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Baylor College of Medicine
Rady Children's Hospital, San Diego
Conditions:
Angelman Syndrome
Nervous System Diseases
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
Angelman syndrome (AS) is a complex genetic disorder that affects the nervous system. The purpose of this study is to determine the effectiveness of certain dietary supplements in treating the symptom...
Detailed Description
AS is a neurologic disorder that may cause developmental delay, mental retardation, severe speech impairment, seizures, small head size, and problems with movement and balance in young children. AS is...
Eligibility Criteria
Inclusion
- Diagnosis of AS
- In stable condition with relatively good control of seizures
- Willing to comply with treatment, study visit schedule, and study assessments
- Willing to take oral or G-tube medication
- Willing to be contacted monthly during the course of the study
- Parent or guardian willing to provide informed consent
Exclusion
- History of liver or kidney disease
- Currently being treated for a serious acute illness
- Known hypersensitivity to any of the study drugs
- Received high-dose folate drug treatment in the 12 months prior to study entry
- Other significant medical problems, including those involving the liver, kidney, or heart
- Other comorbidities, genetic disorders, or extreme prematurity; children with autism are not excluded
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00348933
Start Date
July 1 2006
End Date
February 1 2010
Last Update
September 24 2012
Active Locations (4)
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1
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
2
Children's Hospital Boston
Boston, Massachusetts, United States
3
Greenwood Genetics Center
Greenwood, South Carolina, United States
4
Baylor College of Medicine
Houston, Texas, United States