Placebo-Controlled Pilot Trial of Mecamylamine for Treatment of Autism Spectrum Disorders
This study has been completed.
Sponsor:
Ohio State University
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
L. Eugene Arnold, Ohio State University
ClinicalTrials.gov Identifier:
NCT00773812
First received: October 15, 2008
Last updated: November 6, 2012
Last verified: November 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Neuronal Nicotinic Receptor Modulation in the Treatment of Autism: A Pilot Trial of Mecamylamine |
Resource links provided by NLM:
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 ]
| Enrollment: | 20 |
| Study Start Date: | July 2007 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Active Mecamylamine
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.
Other Name: Inversine
|
|
Placebo Comparator: Placebo
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.
The trial has been completed and published in J. of Child & Adolescent Psychopharmacology. There was no advantage of active drug over placebo.
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 More Information
Additional Information:
Publications:
| Responsible Party: | L. Eugene Arnold, Interim Director of Nisonger Center, Ohio State University |
| ClinicalTrials.gov Identifier: | NCT00773812 History of Changes |
| Other Study ID Numbers: | 2007H0096 |
| Study First Received: | October 15, 2008 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ohio State University:
|
Autistic Disorder Autism Mecamylamine Pervasive Developmental Disorder-Not Otherwise Specified |
Additional relevant MeSH terms:
|
Autistic Disorder Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Mecamylamine Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
Ganglionic Blockers Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Nicotinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013