Status:
COMPLETED
An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
Lead Sponsor:
Enzymotec
Conditions:
Autistic Disorder
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
The primary study objective is to evaluate the efficacy of Vayarin\_005 on ASD related symptoms in children.
Eligibility Criteria
Inclusion
- Males or females, ages 6-17 inclusive
- Must have a valid diagnosis of autism spectrum disorder via a clinical review of the DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)
- Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)
- IQ \>50 evaluated by KBIT-2 or Stanford Binet Fifth Edition
- Able, and likely to fully comply with the study procedures and instructions
- Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
- Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the study Clinician.
- Parents or legal guardian must be able to read, write and speak English
- Parents or legal guardian have given written informed consent to participate in the study
Exclusion
- The subject is significantly underweight under the 5th percentile or obese above the 95th percentile
- Clinically significant systemic illness including hepatic, renal, gastroenterological, metabolic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease, as determined by the study clinician.
- Patients with any primary psychiatric diagnosis other than autism at screening or a known genetic syndrome(s) that cause autism.
- Suspected or established CNS injury
- Change in dosage of psychiatric pharmacotherapy or other medications that have central nervous system effects or that affect performance 4 weeks before study initiation and throughout the study phase
- Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and throughout the study
- Use of dietary supplements, 60 days before study initiation and throughout the study
- Change in educational/behavioral interventions within one month prior to participation or during the study
- A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or substantial psychotic disorder.
- Subject who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
- Current history of physical, sexual, or emotional abuse
- History of alcohol or substance abuse as defined by DSM-IV criteria
- Consumption of \>250 mg/day of caffeine
- History of allergic reactions or sensitivity to marine products and soy
- Has any illness which may jeopardize the participants' health or limit their successful trial completion.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT02222285
Start Date
August 1 2014
End Date
October 1 2017
Last Update
April 11 2018
Active Locations (2)
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1
Institute of Neurology and Neurosurgery at St. Barnabas
Livingston, New Jersey, United States, 07039
2
Spectrum Neuroscience and Treatment Institute
New York, New York, United States, 10021