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Galantamine Versus Placebo in Childhood Autism

NCT00252603 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2007-01-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Galantamine

Sponsors & Collaborators

  • National Alliance for Autism Research

    collaborator OTHER

  • University of Medicine and Dentistry of New Jersey

    lead OTHER

Principal Investigators

  • Sherie Novotny, MD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Completion
2007-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00252603 on ClinicalTrials.gov