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

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ClinicalTrials.gov Identifier: NCT02222285
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Enzymotec

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

Condition or disease Intervention/treatment Phase
Autistic Disorder Other: Medical Food : Vayarin_005 Other: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
Actual Study Start Date : August 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Sequence 3: placebo/placebo
Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment
Other: Placebo
Other Name: Cellulose
Active Comparator: Sequence 2: placebo/ Treatment
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
Other Name: Cellulose
Active Comparator: Sequence one: Treatment/Treatment
Treatment/Treatment- consists of PS_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin_005
Other: Medical Food : Vayarin_005



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinical Global Impression of Severity assesment [ Time Frame: over 14 weeks ]
  2. Clinical Global Impression of Improvement assesment [ Time Frame: over 14 weeks ]
  3. Conners Rating Scale questionnaire [ Time Frame: over 14 weeks ]
  4. Behavior Rating Inventory of Executive function [ Time Frame: over 14 weeks ]
  5. Child Health Questionnaire [ Time Frame: over 14 weeks ]
  6. Caregiver Strain Questionnaire [ Time Frame: over 14 weeks ]
  7. Adverse events monitoring [ Time Frame: over 14 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02222285


Locations
United States, New Jersey
Institute of Neurology and Neurosurgery at St. Barnabas
Livingston, New Jersey, United States, 07039
United States, New York
Spectrum Neuroscience and Treatment Institute
New York, New York, United States, 10021
Sponsors and Collaborators
Enzymotec
Investigators
Principal Investigator: Eric Hollander, M.D. Spectrum Neuroscience and Treatment Institute

Responsible Party: Enzymotec
ClinicalTrials.gov Identifier: NCT02222285     History of Changes
Other Study ID Numbers: Vayarin_005
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: January 2017

Additional relevant MeSH terms:
Disease
Autism Spectrum Disorder
Autistic Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders