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The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related symptoms in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 3: placebo/placebo | Placebo Comparator | Placebo/placebo consists of placebo for 7 weeks followed by 7 weeks of placebo treatment |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Food : Vayarin_005 | Other |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Severity assesment | over 14 weeks | |
| Clinical Global Impression of Improvement assesment | over 14 weeks | |
| Conners Rating Scale questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hollander, M.D. | Spectrum Neuroscience and Treatment Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Neurology and Neurosurgery at St. Barnabas | Livingston | New Jersey | 07039 | United States | ||
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002482 | Cellulose |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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| Other |
|
|
| over 14 weeks |
| Behavior Rating Inventory of Executive function | over 14 weeks |
| Child Health Questionnaire | over 14 weeks |
| Caregiver Strain Questionnaire | over 14 weeks |
| Adverse events monitoring | over 14 weeks |
| Spectrum Neuroscience and Treatment Institute |
| New York |
| New York |
| 10021 |
| United States |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |