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

Sponsor
Enzymotec (Industry)
Overall Status
Completed
CT.gov ID
NCT02222285
Collaborator
(none)
56
Enrollment
2
Locations
3
Arms
38
Actual Duration (Months)
28
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Medical Food : Vayarin_005
  • Other: Placebo
 N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2014
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
Oct 1, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms [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 [over 14 weeks]

    2. Clinical Global Impression of Improvement assesment [over 14 weeks]

    3. Conners Rating Scale questionnaire [over 14 weeks]

    4. Behavior Rating Inventory of Executive function [over 14 weeks]

    5. Child Health Questionnaire [over 14 weeks]

    6. Caregiver Strain Questionnaire [over 14 weeks]

    7. Adverse events monitoring [over 14 weeks]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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

    Sponsors and Collaborators

    • Enzymotec

    Investigators

    • Principal Investigator: Eric Hollander, M.D., Spectrum Neuroscience and Treatment Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Enzymotec
    ClinicalTrials.gov Identifier:
    NCT02222285
    Other Study ID Numbers:
    • Vayarin_005
    First Posted:
    Aug 21, 2014
    Last Update Posted:
    Apr 11, 2018
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Autism Spectrum Disorder
    Autistic Disorder

    Study Results

    No Results Posted as of Apr 11, 2018