Clinical trial NCT02222285: An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
Official title: An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autistic Disorder
Lead sponsor: Enzymotec
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.


Eligibility criteria: Inclusion Criteria:

1. Males or females, ages 6-17 inclusive
2. Must have a valid diagnosis of autism spectrum disorder via a clinical review of the DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)
3. Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)
4. IQ \>50 evaluated by KBIT-2 or Stanford Binet Fifth Edition
5. Able, and likely to fully comply with the study procedures and instructions
6. Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
7. Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the study Clinician.
8. Parents or legal guardian must be able to read, write and speak English
9. Parents or legal guardian have given written informed consent to participate in the study

Exclusion Criteria:

1. The subject is significantly underweight under the 5th percentile or obese above the 95th percentile
2. 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.
3. Patients with any primary psychiatric diagnosis other than autism at screening or a known genetic syndrome(s) that cause autism.
4. Suspected or established CNS injury
5. 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
6. Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and throughout the study
7. Use of dietary supplements, 60 days before study initiation and throughout the study
8. Change in educational/behavioral interventions within one month prior to participation or during the study
9. A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or substantial psychotic disorder.
10. Subject who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
11. Current history of physical, sexual, or emotional abuse
12. History of alcohol or substance abuse as defined by DSM-IV criteria
13. Consumption of \>250 mg/day of caffeine
14. History of allergic reactions or sensitivity to marine products and soy
15. Has any illness which may jeopardize the participants' health or limit their successful trial completion.
16. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety

Primary outcomes:
measure: Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms
timeFrame: over 14 weeks
Secondary outcomes:
measure: Clinical Global Impression of Severity assesment
timeFrame: over 14 weeks
measure: Clinical Global Impression of Improvement assesment
timeFrame: over 14 weeks
measure: Conners Rating Scale questionnaire
timeFrame: over 14 weeks
measure: Behavior Rating Inventory of Executive function
timeFrame: over 14 weeks
measure: Child Health Questionnaire
timeFrame: over 14 weeks
measure: Caregiver Strain Questionnaire
timeFrame: over 14 weeks
measure: Adverse events monitoring
timeFrame: over 14 weeks
Other outcomes:
Locations:
city: Livingston
country: United States
facility: Institute of Neurology and Neurosurgery at St. Barnabas
state: New Jersey
city: New York
country: United States
facility: Spectrum Neuroscience and Treatment Institute
state: New York
Study officials:
affiliation: Spectrum Neuroscience and Treatment Institute
name: Eric Hollander, M.D.
role: PRINCIPAL_INVESTIGATOR
References: