Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065962
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-08-01
Brief Title:
Secretin for the Treatment of Autism
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Multisite Controlled Secretin Trial in Autism
Status:
COMPLETED
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 10000 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 01 ml of their assigned treatment at the appropriate dose 02 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
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 01 ml of their assigned treatment at the appropriate dose 02 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NICHD-23 | None | None | None |
| 57-937 | None | None | None |
| 5P01HD035465 | NIH | None | None |
| Supplement CRC99-3 | None | None | None |
| 3P01HD035468 | NIH | None | httpsreporternihgovquickSearch3P01HD035468 |