Status:
COMPLETED
Early Pharmacotherapy Aimed at Neuroplasticity in Autism : Safety and Efficacy
Lead Sponsor:
Chugani, Diane C.
Conditions:
Autism
Eligibility:
All Genders
2-6 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy, safety, and population pharmacokinetics and determinants of drug responses to buspirone in children with autism using a randomized, double blind...
Detailed Description
Autism is a neurodevelopmental disorder defined as qualitative impairment in social interaction and communication and restrictive stereotype patterns of behavior, interests and activities. Pharmacolog...
Eligibility Criteria
Inclusion
- Meet study definition for the diagnosis of autistic disorder
- Age 2 to 6 (male or female)
- Informed Consent
Exclusion
- Clinical or lab evidence of renal or hepatic disease
- Treatment with any medication known to alter the activity of the CYP3A4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 3 months
- Use of centrally acting drugs during the 6 weeks prior or during the study
- Presence or history of neurological disorders, including seizure disorders
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00166621
Start Date
March 1 2004
End Date
August 1 2005
Last Update
July 20 2011
Active Locations (1)
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1
PET Center/Children's Hospital of Michigan
Detroit, Michigan, United States, 48201