Expired Study
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Columbus, Ohio 43210


Purpose:

The purpose of this study is to examine the safety and efficacy of mecamylamine for the core symptoms of autism.


Study summary:

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 pharmacotherapeutic trial will be conducted as a direct result of findings of a nicotinic receptor abnormality in autopsied brain tissue from individuals who suffered from autism. A pharmacological agent, mecamylamine, with specificity for the nicotinic receptors implicated in autism, will be tested in children with autism spectrum disorder. Twenty children who meet inclusion/exclusion criteria will be randomized in a 2:3 ratio to 14 weeks of either matched placebo (n=8) or mecamylamine (n=12). Children randomized to placebo who do not respond will be given the opportunity to enroll in a ten week open label extension. The trial has been completed and published in J. of Child & Adolescent Psychopharmacology.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT00773812


Primary Contact:

Principal Investigator
L E Arnold, M.D.
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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