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

Autistic Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02222285
• Other study ID #: Vayarin_005
• Status: Completed
• Phase: N/A
• First received: August 12, 2014
• Last updated: April 10, 2018
• Start date: August 2014
• Est. completion date: October 2017

Study information

• Verified date: January 2017
• Source: Enzymotec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Disease

Intervention

Other:
• Medical Food : Vayarin_005

• Placebo

Locations

Country	Name	City	State
United States	Institute of Neurology and Neurosurgery at St. Barnabas	Livingston	New Jersey
United States	Spectrum Neuroscience and Treatment Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Enzymotec

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Global Impression of Severity assesment		over 14 weeks
Secondary	Clinical Global Impression of Improvement assesment		over 14 weeks
Secondary	Conners Rating Scale questionnaire		over 14 weeks
Secondary	Behavior Rating Inventory of Executive function		over 14 weeks
Secondary	Child Health Questionnaire		over 14 weeks
Secondary	Caregiver Strain Questionnaire		over 14 weeks
Secondary	Adverse events monitoring		over 14 weeks