- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065962
Secretin for the Treatment of Autism
Multisite Controlled Secretin Trial in Autism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism is a disorder characterized by impairments of social interactions, verbal and nonverbal communication, and preoccupation with unusual activities or interests, particularly stereotyped or repetitive movements. This debilitating disorder is estimated to occur in 2 to 10 of every 10,000 births. A primary focus in pyschopharmacological intervention has been to treat specific associated symptoms, such as hyperactivity, aggressiveness, and temper tantrums; there are few pharmacologic treatments directed toward core autistic symptoms.
Secretin is a gut hormone with binding sites in the brain. Previous research has described three patients with autism who underwent diagnostic endoscopy for gastrointestinal complaints and experienced dramatic improvement in autistic symptoms following the administration of intravenous secretin given as part of endoscopy. Though the results of this single, uncontrolled study have limited interpretive value, many autistic children have been exposed and continue to be exposed to this potential treatment in an uncontrolled manner. This double blind, placebo-controlled trial will evaluate the safety and efficacy of secretin for the treatment of autism.
Participants will be randomly assigned to one of three treatment groups: synthetic porcine secretin (sPS), biologically derived porcine secretin (bPS), or placebo. Each participant will be given an initial intravenous dose of 0.1 ml of their assigned treatment at the appropriate dose (0.2 ug for sPS and 1 CU for bPS). If no allergic reaction occurs within one minute, the participants will continue in the study and receive the full remaining dose over one minute. Participants will be evaluated one week before and four weeks after infusion for social, communication, and behavioral functioning as measured by Autistic Diagnostic Observation Schedule Generic (by blinded raters); Rimland Questionnaires (by parents and teachers); Expressive Vocabulary Test; MacArthur Communication Inventory (by parents and teachers); and Aberrant Behavior Checklist (by parents and teachers). Participants will also have a physical exam and blood and urine tests. After completion of preliminary data analysis, placebo patients will be offered open label therapy if appropriate.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80218
- Children's Hospital
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Washington
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Seattle, Washington, United States, 98195-1525
- Center on Human Development and Disability
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Autism based on DSM-IV criteria
- IQ > 35
- Medically fit for the study in the judgment of the study officials
Exclusion Criteria
- Prior administration of secretin
- Acute or chronic pancreatitis
- Use of anticholinergics within 72 hours of study entry or anticipated need for anticholinergics during study
- Allergies to pork products
- Use of investigational drug within 1 month of study entry
- Change in any medication or other therapeutic modality being used to treat any neurodevelopmental or gastrointestinal symptoms of the underlying autism disorder within 1 month of study entry
- Any medical condition which, in the judgment of the investigator, would make the patient unable to safely participate in the study or comply with all study procedures
- Any medical diagnosis which could account for autistic spectrum disorder (i.e., Rett syndrome, Fragile X, tuberous sclerosis, disintegrative disorder, epilepsy, Landau Kleffner, other mental retardation syndromes, or history of severe motor delays or current sensory or motor impairment such as cerebral palsy)
- Hearing or visual impairments
- Use of psychotropic medications (except for occasional symptomatic use for sleep, etc.) within 6 months of study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Collaborators and Investigators
Investigators
- Study Director: Alan Unis, MD, University of Washington
- Principal Investigator: Geraldine Dawson, PhD, University of Washington
- Study Director: Edward Goldson, MD, University of Colorado, Denver
- Principal Investigator: Sally Rogers, PhD, University of Colorado, Denver
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5P01HD035465 (U.S. NIH Grant/Contract)
- NICHD-23
- 57-937
- Supplement CRC99-3
- 3P01HD035468 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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