Status:
COMPLETED
Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Autism Speaks
Conditions:
Autistic Disorder
Pervasive Developmental Disorder
Eligibility:
All Genders
4-12 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.
Detailed Description
This is a placebo-controlled pilot clinical trial of a nicotinic agent based on evidence that a disturbance occurs in nicotinic cholinergic transmission in the brain of autistic children. This pharmac...
Eligibility Criteria
Inclusion
- Autistic Disorder or Pervasive Developmental Disorder-Not Otherwise Specified
- Age 4-12
- General good health
- IQ of \>=36 or mental age of \>=18 months
- Parent/caregiver willingness to accompany child to clinic and monitor for side effects
Exclusion
- Unstable Seizure Disorder
- Psychoactive medication in the process of adjustment
- Antipsychotic medication in previous 3 months before baseline
- Systemic corticoids (inhalers allowed)
- Planned beginning of major behavioral intervention in 3 months of study or the 2 months prior to the study.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00773812
Start Date
July 1 2007
End Date
November 1 2012
Last Update
January 13 2017
Active Locations (1)
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1
Nisonger Center
Columbus, Ohio, United States, 43210