Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00773812
Study type Interventional
Source Ohio State University
Contact
Status Completed
Phase Phase 1
Start date July 2007
Completion date November 2012

See also
  Status Clinical Trial Phase
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Completed NCT02568631 - Improving Social Cognition for Adults With ASD by the Serious Game JeStiMulE Versus Controls N/A
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Completed NCT02369445 - Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention N/A
Completed NCT01617460 - A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Autistic Disorder Phase 3
Completed NCT01592747 - Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine Phase 2
Completed NCT01400269 - An Evaluation of a Developmentally-Based Parent Training Program for Children With Autism N/A
Active, not recruiting NCT02442115 - Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Completed NCT00926471 - Social Skills and Anxiety Reduction Treatment for Children and Adolescents With Autism Spectrum Disorders Phase 1
Completed NCT00692315 - Treating Oxidative Stress in Children With Autism N/A
Completed NCT00365859 - Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD) Phase 3
Completed NCT00198107 - Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism Phase 3
Completed NCT00095420 - Relationship Training for Children With Autism and Their Peers N/A
Completed NCT00027404 - Study of Fluoxetine in Adults With Autistic Disorder N/A
Recruiting NCT05910502 - Project AFECT (Autism Family Empowerment Coaching and Training Program) N/A
Completed NCT04820998 - Living in a Precarious Situation With an Autistic Child: What Are the Issues at Stake for Support in Care
Withdrawn NCT05413187 - A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder Phase 2
Recruiting NCT02275455 - Design Of WELL Being Monitoring Systems, Application in Autism N/A
Completed NCT02766101 - Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges N/A
Completed NCT01977248 - Sensorimotor Affect Relationship-based Therapy (SMART) for Children With Autism Spectrum Disorders Ages 2-12 N/A