An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)

NCT02222285 | Completed

• 1 other identifier: Vayarin_005
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

The primary study objective is to evaluate the efficacy of Vayarin\_005 on ASD related symptoms in children.

Conditions

Autistic Disorder

Outcome Measures

Primary Outcomes (1)

• Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms

  A significant reduction from baseline to endpoint on the Aberrant Behavior Checklist (ABC) compared to patients administered placebo

  over 14 weeks

Secondary Outcomes (7)

• Clinical Global Impression of Severity assesment

  over 14 weeks

• Clinical Global Impression of Improvement assesment

  over 14 weeks

• Conners Rating Scale questionnaire

  over 14 weeks

• Behavior Rating Inventory of Executive function

  over 14 weeks

• Child Health Questionnaire

  over 14 weeks

Study Arms (3)

Sequence 3: placebo/placebo

PLACEBO COMPARATOR

Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment

Other: Placebo

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

Other: Medical Food : Vayarin_005; Other: Placebo

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

Other: Medical Food : Vayarin_005

Interventions

Medical Food : Vayarin_005 OTHER

Sequence 2: placebo/ Treatment; Sequence one: Treatment/Treatment

Placebo OTHER

Also known as: Cellulose

Sequence 2: placebo/ Treatment; Sequence 3: placebo/placebo

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enzymotec: lead

Study Sites (2)

Institute of Neurology and Neurosurgery at St. Barnabas

Livingston, New Jersey, 07039, United States

Location

Spectrum Neuroscience and Treatment Institute

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Eric Hollander, M.D.

  Spectrum Neuroscience and Treatment Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 21, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2017-01

Locations

US (2)