Autistic DisorderNCT02222285
An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
A study testing Medical Food : Vayarin_005 in people with Autistic Disorder, run by Enzymotec at 2 sites in United States.
Trial summary
The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Medical Food : Vayarin_005
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females, ages 6-17 inclusive
- Must have a valid diagnosis of autism spectrum disorder via a clinical review of the DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)
- Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)
- IQ >50 evaluated by KBIT-2 or Stanford Binet Fifth Edition
- Able, and likely to fully comply with the study procedures and instructions
- Subjects with mood, anxiety, or disruptive behavior disorders will be allowed to participate in the study provided they do not meet any exclusionary criteria.
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- Have normal physical examination and laboratory test results at screening. If abnormal, the finding(s) must be deemed clinically insignificant by the study Clinician.
- Parents or legal guardian must be able to read, write and speak English
- Parents or legal guardian have given written informed consent to participate in the study
Who cannot join
- The subject is significantly underweight under the 5th percentile or obese above the 95th percentile
- 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.
- Patients with any primary psychiatric diagnosis other than autism at screening or a known genetic syndrome(s) that cause autism.
- Suspected or established CNS injury
- 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
- Use of alpha-agonists, or ADHD medications 4 weeks prior to study initiation and throughout the study
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- Use of dietary supplements, 60 days before study initiation and throughout the study
- Change in educational/behavioral interventions within one month prior to participation or during the study
- A known comorbid psychiatric diagnoses of bipolar I disorder, suicidality, or substantial psychotic disorder.
- Subject who has participated in another clinical trial within 30 days of screening for this trial and/or any experimental treatment for this population
- Current history of physical, sexual, or emotional abuse
- History of alcohol or substance abuse as defined by DSM-IV criteria
- Consumption of >250 mg/day of caffeine
- History of allergic reactions or sensitivity to marine products and soy
- Has any illness which may jeopardize the participants' health or limit their successful trial completion.
- Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the patient safety
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Institute of Neurology and Neurosurgery at St. Barnabas
Livingston, New Jersey, 07039
Spectrum Neuroscience and Treatment Institute
New York, New York, 10021
About this study
The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.
- Conditions
- Autistic Disorder
- Being tested
- Medical Food : Vayarin_005, Placebo
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Food : Vayarin_005Other
PlaceboOther
Also called Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Sequence 3: placebo/placebo | Placebo comparator | Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment Receives: Other: Placebo |
| Sequence 2: placebo/ Treatment | Active comparator | Sequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin_005 Receives: Other: Medical Food : Vayarin_005; Other: Placebo |
| Sequence one: Treatment/Treatment | Active comparator | Treatment/Treatment- consists of PS_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin_005 Receives: Other: Medical Food : Vayarin_005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: over 14 weeks
Secondary outcomes (7)
Clinical Global Impression of Severity assesment
Measured: over 14 weeks
Clinical Global Impression of Improvement assesment
Measured: over 14 weeks
Conners Rating Scale questionnaire
Measured: over 14 weeks
Behavior Rating Inventory of Executive function
Measured: over 14 weeks
Child Health Questionnaire
Measured: over 14 weeks
Caregiver Strain Questionnaire
Measured: over 14 weeks
Adverse events monitoring
Measured: over 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionMay 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymotec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Hollander, M.D., Principal investigator, Spectrum Neuroscience and Treatment Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222285
- Sponsor's protocol ID
- Vayarin_005
- Status last verified
- Jan 2017
- First submitted
- 12 Aug 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT02222285
- Acronym / sponsor ID
- Vayarin_005
- Conditions
- Autistic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- EnzymotecIndustry (pharma, biotech, devices)
- Study start
- Aug 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 21 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 3: placebo/placebo | Placebo comparator | Other: PlaceboPlacebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment |
| Sequence 2: placebo/ Treatment | Active comparator | Other: Medical Food : Vayarin_005, Other: PlaceboSequence 2: placebo/ Treatment , consists of placebo for 7 weeks followed by 7 weeks of treatment with Vayarin_005 |
| Sequence one: Treatment/Treatment | Active comparator | Other: Medical Food : Vayarin_005Treatment/Treatment- consists of PS_005 for 7 weeks followed by 7 weeks of additional treatment with Vayarin_005 |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Males or females, ages 6-17 inclusive
- Must have a valid diagnosis of autism spectrum disorder via a clinical review of the DSM-IV, confirmed by Autism Diagnostic Observation Schedule (ADOS)
- Clinical Global Impression Scale of Severity of Illness for Pervasive Developmental Disorders (CGI-S-PDD) rating of 4 or higher (moderately ill or worse)
- IQ >50 evaluated by KBIT-2 or Stanford Binet Fifth Edition
- Able, and likely to fully comply with the study procedures and instructions
Key exclusion criteria (16 listed)
- The subject is significantly underweight under the 5th percentile or obese above the 95th percentile
- 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.
- Patients with any primary psychiatric diagnosis other than autism at screening or a known genetic syndrome(s) that cause autism.
- Suspected or established CNS injury
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Food : Vayarin_005 | Other | Sequence 2: placebo/ Treatment, Sequence one: Treatment/Treatment |
| PlaceboAlso: Cellulose | Other | Sequence 2: placebo/ Treatment, Sequence 3: placebo/placebo |
Primary outcome
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
7 secondary outcomes
Clinical Global Impression of Severity assesment
Time frame: over 14 weeks
Clinical Global Impression of Improvement assesment
Time frame: over 14 weeks
Conners Rating Scale questionnaire
Time frame: over 14 weeks
Behavior Rating Inventory of Executive function
Time frame: over 14 weeks
Child Health Questionnaire
Time frame: over 14 weeks
Caregiver Strain Questionnaire
Time frame: over 14 weeks
Adverse events monitoring
Time frame: over 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Hollander, M.D. principal investigator
Spectrum Neuroscience and Treatment Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Food : Vayarin_005 in people with Autistic Disorder, run by Enzymotec at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist will be used to asses Autism spectrum symptoms (time frame: over 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.