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NCT02222285
An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
NA trial testing Medical Food : Vayarin_005 in Autistic Disorder in 56 participants. Completed in 1 October 2017.
1 May 2017
Quick facts
| Lead sponsor | Enzymotec |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | other |
| Enrollment | 56 |
| Start date | 1 August 2014 |
| Primary completion | 1 May 2017 |
| Estimated completion | 1 October 2017 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Medical Food : Vayarin_005
- Placebo
Conditions studied
- Autistic Disorder — all drugs for Autistic Disorder →
Sponsor
Enzymotec
Who can join
Adults 6 to 17, any sex, with Autistic Disorder. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
The primary study objective is to evaluate the efficacy of Vayarin\_005 on ASD related symptoms in children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02222285
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Autistic Disorder
Currently open trials in the same condition.
- NCT05910502 — Project AFECT (Autism Family Empowerment Coaching and Training Program) · NA · active not recruiting
- NCT06227780 — Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders · NA · recruiting
- NCT05176808 — Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02222285 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Enzymotec
- Last refreshed: 10 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02222285.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing