Autism Clinical Trial
Official title:
Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism
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.
Status | Recruiting |
Enrollment | 84 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 18 Years |
Eligibility |
Inclusion criteria: - A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified (PDD-NOS), given by a child neurologist. - Age: 10-18 years. - A signed parental consent form. Exclusion criteria: - Evidence for one of the following conditions: - an underlying infectious disease - chromosomal abnormality - metabolic disorder - specific brain related disorder (such as tuberous sclerosis) - history of fetal cytomegalovirus infection - birth asphyxia - a history of major head injury - a chronic use of non-steroidal anti-inflammatory drugs, (NSAID) - known brain damage - Epilepsy - Abnormal Electro-cardiogram (ECG) - Epileptiform EEG - Use of psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents within the past month. - Lack of cooperation in the screening phase |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Sheba Medical Center | Tel Hashomer | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center | The Israeli Society of Clinical Pediatrics (HIPAK) |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Core autistic symptoms (ATEC) | The parents will fill out this questionnaire about their child once every 4 weeks during the first Phase (12 weeks)- the Treatment phase. | Once every 4 weeks during the first three mounth | No |
Primary | Side effects and adverse events questionnaire | A detailed parent questionnaire to assess side effects and adverse events. The parents will fill out these questionnaires about their child once every 4 weeks during the first phase(12 weeks)- which is the treatment phase. | Once every 4 weeks during the first phase(12 weeks) | Yes |
Secondary | Linguistic performance (CELF-4) | The subject will be diagnosed on his Linguistic performance - using the CELF-4 diagnosis. | After 6 mounth of washout | No |
Secondary | Adaptive functioning (Vineland-II) | The parents will be interviwed using the Adaptive functioning (Vineland-II) | After 6 mounth of washout | No |
Secondary | Comorbid behaviors (CSI-4 questionnaire) | The parents will fill out the Comorbid behaviors (CSI-4) questionnaire | After 6 mouth of washout | No |
Secondary | Executive functions (BRIEF questionnaire) | The parents will fill out the Executive functions (BRIEF) questionnaire. | After 6 mounth of washout | No |
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