drugset / Trial / NCT01098383
Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism Spectrum Disorders
Phase 4
Unknown
84 enrolled
Sheba Medical Center
The Israeli Society of Clinical Pediatrics (HIPAK) · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.
Timeline
- Start
- 2010-03
- Primary completion
- 2017-12
- Completion
- 2017-12
Publications
- 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.
- Ure A, Cox GR, Haslam R, Williams K. Acetylcholinesterase inhibitors for autistic spectrum disorders. Cochrane Database Syst Rev. 2023 Jun 1;6(6):CD013851. doi: 10.1002/14651858.CD013851.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Choline | Other / unclassified | 250 mg | Oral |
| Subject | Choline | Other / unclassified | 500 mg | Oral |
| Subject | Donepezil | Small molecule | 5 mg | Oral |