Secretin for the Treatment of Autism

NCT00065962 | Completed Phase 3

• 5 other identifiers: 5P01HD035465NICHD-2357-937Supplement CRC99-33P01HD035468
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

Many drugs used to treat autism target specific symptoms, such as hyperactivity and aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction and communication. This study will evaluate two forms of the drug secretin for the treatment of core autistic symptoms.

Conditions

Autism

Keywords

Pervasive Developmental Disorders; Secretin, synthetic porcine; Secretin, biological porcine; Autism Diagnostic Observation Schedule - Generic (ADOS-G); Rimland Questionnaire; Expressive Vocabulary Test; MacArthur Communication Inventory; Aberrant Behavior Checklist

Interventions

secretin, synthetic porcine DRUG

secretin, biologically derived porcine DRUG

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Autism based on DSM-IV criteria
• IQ \> 35
• Medically fit for the study in the judgment of the study officials

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

Children's Hospital

Denver, Colorado, 80218, United States

Location

Center on Human Development and Disability

Seattle, Washington, 98195-1525, United States

Location

Related Publications (2)

• Unis AS, Munson JA, Rogers SJ, Goldson E, Osterling J, Gabriels R, Abbott RD, Dawson G. A randomized, double-blind, placebo-controlled trial of porcine versus synthetic secretin for reducing symptoms of autism. J Am Acad Child Adolesc Psychiatry. 2002 Nov;41(11):1315-21. doi: 10.1097/00004583-200211000-00012.

  PMID: 12410073 BACKGROUND

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Child Development Disorders, Pervasive

Interventions

Secretin

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Alan Unis, MD

  University of Washington

  STUDY DIRECTOR

• Geraldine Dawson, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Edward Goldson, MD

  University of Colorado, Denver

  STUDY DIRECTOR

• Sally Rogers, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 1, 2003
• First Posted: August 5, 2003
• Study Start: June 1, 1999
• Study Completion: May 1, 2000
• Last Updated: June 24, 2005

Record last verified: 2003-06

Locations

US (2)