At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Galantamine Versus Placebo in Childhood Autism
In Brief
A Phase 3 clinical trial evaluating Galantamine for Autism and Childhood Autism. Completed, across 1 site.
Detailed Summary
Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Autism severely impacts both the affected individual and family members. The proposed study is designed to assess the efficacy of treatment with Galantamine vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. We therefore hypothesize: 1. Galantamine will be superior to placebo in the acute treatment of global autism. 2. Galantamine will be superior to placebo in improving functional ability. 3. Galantamine will be superior to placebo in improving language function. 4. Galantamine will be superior to placebo improving irritable and hyperactive behavior. 5. Galantamine will be superior to placebo in improving social deficits.