AutismPhase 3NCT00065962
Secretin for the Treatment of Autism
A Phase 3 study testing secretin, synthetic porcine and secretin, biologically derived porcine in people with Autism, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- secretin, synthetic porcine and secretin, biologically derived porcine
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 1999to May 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism based on DSM-IV criteria
- IQ > 35
- Medically fit for the study in the judgment of the study officials
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital
Denver, Colorado, 80218
Center on Human Development and Disability
Seattle, Washington, 98195-1525
About this study
Official title: Multisite Controlled Secretin Trial in Autism
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.
Read the 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.
- Conditions
- Autism
- Being tested
- secretin, synthetic porcine, secretin, biologically derived porcine
- 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
- Medical subject headings
- Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
secretin, synthetic porcineDrug
secretin, biologically derived porcineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startJun 1999
- Study completionMay 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Investigators
- Alan Unis, MD, Study director, University of WashingtonGeraldine Dawson, PhD, Principal investigator, University of WashingtonEdward Goldson, MD, Study director, University of Colorado, DenverSally Rogers, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065962
- Sponsor's protocol ID
- 5P01HD035465
- Other IDs
- NICHD-23, 57-937, 5P01HD035465, Supplement CRC99-3, 3P01HD035468
- Status last verified
- Jun 2003
- First submitted
- 1 Aug 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 12410073Iffland 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.
PubMed 37811711
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multisite Controlled Secretin Trial in Autism
- ClinicalTrials.gov ID
- NCT00065962
- Acronym / sponsor ID
- 5P01HD035465
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jun 1999
- Study completion
- May 2000
- First posted
- 5 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Autism based on DSM-IV criteria
- IQ > 35
- Medically fit for the study in the judgment of the study officials
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| secretin, synthetic porcine | Drug | – |
| secretin, biologically derived porcine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 12410073Unis 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.
- Derived from this study: PubMed 37811711Iffland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Unis, MD study director
University of Washington
Geraldine Dawson, PhD principal investigator
University of Washington
Edward Goldson, MD study director
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing secretin, synthetic porcine and secretin, biologically derived porcine in people with Autism, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065962, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.