NCT00773812

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Autistic Disorder
• Pervasive Developmental Disorder

Interventions

Type	Name	Description
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.
DRUG	placebo	One pill is taken once daily.

Timeline

• Start date: 2007-07-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2008-10-16
• Last updated: 2017-01-13

Locations

1 site across 1 country: United States