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Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism Spectrum Disorders

NCT01098383 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-10-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Acetyl-Choline Esterase Inhibitors and Choline supplements

Donepezil will be used at initial dose of 2.5 mg/day (during the first two weeks), and an increased dose of 5 mg/day (from the 3rd week and on), according to the treatment protocol listed below. The tablets will be taken during breakfast. AChE inhibitors are considered as potent agents for clinical use in Alzheimer's and Parkinson's dementias (Wevers \& Schroder, 1999) and treatment with these agents was proven to be well-tolerated, safe and effective in these populations. Cholinergic side effects are generally transient, mild and dose-related, and primarily include diarrhea, nausea, and vomiting. Choline tablets will be taken at daily doses of 250 mg (in children with up to 40 kg body weight) and 500 mg (in children with more than 40 kg body weight), based on half of the adult daily dose.

DRUG

Indistinguishable placebo tablets, matching both donepezil and choline

Indistinguishable placebo tablets, matching both donepezil and choline, will be given in the same amounts and schedules

Sponsors & Collaborators

  • The Israeli Society of Clinical Pediatrics (HIPAK)

    collaborator UNKNOWN

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Lidia Gabis, MD · Sheba Medical Center

  • Dorit Ben-Shalom, Ph.D · Ben-Gurion University of the Negev

  • Shefer Shahar, Dr. · Sheba Medical Center

  • Rotem Chayu Ben-Hur, MA · Sheba Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01098383 on ClinicalTrials.gov