Status:
COMPLETED
Study on Tolerability of Levodopa/Carbidopa in Children With Angelman Syndrome
Lead Sponsor:
Boston Children's Hospital
Conditions:
Angelman Syndrome
Eligibility:
All Genders
4-12 years
Phase:
PHASE1
Brief Summary
This study is designed to determine the highest dose of levodopa/carbidopa that can be tolerated without any serious side effects by children with Angelman syndrome. It has been hypothesized that lev...
Detailed Description
Levodopa is a prodrug that "delivers" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa. Animal studies have ...
Eligibility Criteria
Inclusion
- Angelman syndrome, confirmed by molecular testing
- Must be willing to come for research visit on 2 days, exactly 1 week apart
Exclusion
- On levodopa, carbidopa, or any dopamine agonists in the 2 weeks prior to participation
- Other medical conditions that may be associated with developmental or cognitive delays
- More than 2 clinical seizures per month
- Used monoamine oxidase (MAO) inhibitors within the last 2 weeks
- Used phenytoin within the last 2 weeks
- Used phenothiazines, butyrophenones, and thioxanthenes within last 2 weeks
- Hypersensitive to levodopa or carbidopa
- Cardiovascular disease or instability
- Respiratory diseases, including asthma, emphysema, chronic cough, and shortness of breath
- Liver disease
- Stomach or intestinal ulcers
- Kidney disease
- Hematological problems, including anemia, leucopenia, and thrombocytopenia
- Used investigational drugs/interventions within the past three months
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00829439
Start Date
January 1 2009
End Date
June 1 2010
Last Update
November 21 2016
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115