NCT02222285CompletedNot Applicable
An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
Enzymotec3 sites in 1 country56 target enrollmentStarted: August 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 3
- Primary Endpoint
- Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms
Study Overview
Brief Summary
The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Sequence 3: placebo/placebo
Placebo Comparator
Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment
Intervention: Placebo (Other)
Sequence 2: placebo/ Treatment
Active Comparator
Sequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin_005
Intervention: Medical Food : Vayarin_005 (Other)
Sequence 2: placebo/ Treatment
Active Comparator
Sequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin_005
Intervention: Placebo (Other)
Sequence one: Treatment/Treatment
Active Comparator
Treatment/Treatment- consists of PS_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin_005
Intervention: Medical Food : Vayarin_005 (Other)
Outcomes
Primary Outcomes
Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms
Time Frame: over 14 weeks
A significant reduction from baseline to endpoint on the Aberrant Behavior Checklist (ABC) compared to patients administered placebo
Secondary Outcomes
- Adverse events monitoring(over 14 weeks)
- Conners Rating Scale questionnaire(over 14 weeks)
- Child Health Questionnaire(over 14 weeks)
- Caregiver Strain Questionnaire(over 14 weeks)
- Clinical Global Impression of Severity assesment(over 14 weeks)
- Behavior Rating Inventory of Executive function(over 14 weeks)
- Clinical Global Impression of Improvement assesment(over 14 weeks)
Investigators
Study Sites (3)
Loading locations...
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