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-IVRepetitive 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
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