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Secretin for the Treatment of Autism Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Secretin for the Treatment of Autism conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Secretin for the Treatment of Autism Clinical research trials and Secretin for the Treatment of Autism medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Secretin for the Treatment of Autism. Secretin for the Treatment of Autism Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Secretin for the Treatment of Autism clinical trial. Subjects typically recieve the finest healthcare available for their Secretin for the Treatment of Autism condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "S" Clinical Trials Conditions > Secretin for the Treatment of Autism  Secretin for the Treatment of Autism
Secretin for the Treatment of Autism
For Condition: Autism
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute on Deafness and Other Communication Disorders (NIDCD)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 3 Years/12 Years
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 85
Location and Contact Information:
Overall Study Official:
GeraldineDawson, Principal Investigator, University of Washington
Children's Hospital
Denver, Colorado, 80218
United States
Center on Human Development and Disability
Seattle, Washington, 98195-1525
United States
Additional Information:
Study ID Numbers: 5P01HD35465; Supplement CRC99-3,NICHD-23,57-937,3 PO1 HD35468,5 PO1 HD35465
Study Start Date: June 1999
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065962
Other Autism Studies:
1. Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
2. Valproate Response in Aggressive Autistic Adolescents
3. Longitudinal and Biological Study of Childhood Disintegrative Disorder
4. Synthetic Human Secretin in Children with Autism
5. Synthetic Human Secretin in Children with Autism and Gastrointestinal Dysfunction
Related Studies:
Other Autism Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Secretin for the Treatment of Autism
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