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Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders

Information source: Ohio State University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Autistic Disorder; Pervasive Developmental Disorder

Intervention: mecamylamine (Drug); placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ohio State University

Official(s) and/or principal investigator(s):
L E Arnold, M.D., Principal Investigator, Affiliation: Ohio State University

Summary

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

Clinical Details

Official title: Neuronal Nicotinic Receptor Modulation in the Treatment of Autism: A Pilot Trial of Mecamylamine

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary measure will be a global composite derived by calculating the z scores on each measure other than CGI from published norms (or from the baseline descriptives, then averaging the z scores of the various outcome measures for each individual.

Secondary outcome:

OSU Autism Rating Scale-DSM-IV

Repetitive Behavior Questionnaire

Aberrant Behavior Checklist

Ohio Autism Clinical Impressions Scale

Social Responsiveness Scale

Expressive Vocabulary test-Second Edition

Adverse Experience checklist and AE log

Cognitive Battery

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 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. There was no advantage of active drug over placebo.

Eligibility

Minimum age: 4 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Nisonger Center, Columbus, Ohio 43210, United States
Additional Information

Ohio State University Research Unit for Pediatric Pyschopharmocology Website

Starting date: July 2007
Last updated: April 7, 2014

Page last updated: August 23, 2015

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