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

NCT ID: NCT02222285

Last Updated: 2018-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-10-31

Brief Summary

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

Conditions

Autistic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Sequence 3: placebo/placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Sequence 2: placebo/ Treatment

Sequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin\_005

Group Type: ACTIVE_COMPARATOR

Medical Food : Vayarin_005

Intervention Type: OTHER

Placebo

Intervention Type: OTHER

Sequence one: Treatment/Treatment

Treatment/Treatment- consists of PS\_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin\_005

Group Type: ACTIVE_COMPARATOR

Medical Food : Vayarin_005

Intervention Type: OTHER

Interventions

Medical Food : Vayarin_005

Intervention Type: OTHER

Placebo

Intervention Type: OTHER

Other Intervention Names

Cellulose

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enzymotec

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Hollander, M.D.

Role: PRINCIPAL_INVESTIGATOR

Spectrum Neuroscience and Treatment Institute

Locations

Institute of Neurology and Neurosurgery at St. Barnabas

Livingston, New Jersey, United States

Spectrum Neuroscience and Treatment Institute

New York, New York, United States

Countries

United States

Other Identifiers

Vayarin_005

Identifier Type: -

Identifier Source: org_study_id