A Pilot Trial of Mecamylamine for the Treatment of Autism - Full Text View

Sponsors and Collaborators:	Ohio State University Autism Speaks
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00773812

Purpose

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

Condition	Intervention	Phase
Autistic Disorder Pervasive Developmental Disorder	Drug: mecamylamine Drug: placebo	Phase II

MedlinePlus related topics: Autism Developmental Disabilities

Drug Information available for: Mecamylamine Mecamylamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Factorial Assignment, Safety/Efficacy Study
Official Title:	Neuronal Nicotinic Receptor Modulation in the Treatment of Autism: A Pilot Trial of Mecamylamine

Further study details as provided by Ohio State University:

Primary Outcome Measures:

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. [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10,12, and 14. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

OSU Autism Rating Scale-DSM-IV [ Time Frame: Baseline, week 6, 8, and 14. ] [ Designated as safety issue: No ]
Repetitive Behavior Questionnaire [ Time Frame: Baseline, week 2, 4, 6, 8, 10, 12, and 14 ] [ Designated as safety issue: No ]
Aberrant Behavior Checklist [ Time Frame: Baseline, week 2, 4, 6, 8, 10, 12, and 14. ] [ Designated as safety issue: No ]
Ohio Autism Clinical Impressions Scale [ Time Frame: Baseline, weeks 1, 2, 4, 6, 7, 8, 9, 10, 12, and 14. ] [ Designated as safety issue: No ]
Social Responsiveness Scale [ Time Frame: Baseline, weeks 2, 4, 6, 8, 10, 12, and 14. ] [ Designated as safety issue: No ]
Expressive Vocabulary test-Second Edition [ Time Frame: Baseline and week 14 ] [ Designated as safety issue: No ]
Adverse Experience checklist and AE log [ Time Frame: Baseline, weeks 1, 2, 4, 6, 7, 8, 9, 10, 12, and 14. ] [ Designated as safety issue: Yes ]
Cognitive Battery [ Time Frame: baseline, weeks 6, 8, and 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental There will be 12 children in this arm. These children will receive the active medication (mecamylamine).	Drug: mecamylamine The dosage is titrated at 6 weeks of .5mg, 2 weeks of 2.5 mg, and 6 weeks of 5.0 mg. One pill is taken once daily.
2: Placebo Comparator There will be 8 children in this arm. These children will receive placebo instead of the active medication.	Drug: placebo One pill is taken once daily.

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.

Eligibility

Ages Eligible for Study:	4 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773812

Locations

United States, Ohio
Nisonger Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Bethany N Bates, B.A. 614-292-3698 bethany.bates@osumc.edu
Principal Investigator: L. Eugene Arnold, M.D.
Sub-Investigator: Michael Aman, PhD
Sub-Investigator: Yaser Ramadan, M.D.

Sponsors and Collaborators

Ohio State University

Autism Speaks

Investigators

Principal Investigator:

L E Arnold, M.D.

Ohio State University

More Information

Ohio State University Research Unit for Pediatric Pyschopharmocology Website This link exits the ClinicalTrials.gov site

Responsible Party:	Ohio State University Nisonger Center ( L. Eugene Arnold, M.D.; Prinicipal Investigator )
Study ID Numbers:	2007H0096
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773812
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

Autistic Disorder
Autism
Mecamylamine
Pervasive Developmental Disorder-Not Otherwise Specified

Study placed in the following topic categories:

Child Development Disorders, Pervasive
Developmental Disabilities
Mental Disorders

Autistic Disorder
Mental Disorders Diagnosed in Childhood
Mecamylamine

Additional relevant MeSH terms:

Ganglionic Blockers
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Nicotinic Antagonists
Physiological Effects of Drugs
Cardiovascular Agents

Antihypertensive Agents
Cholinergic Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009