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This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasimelteon | Experimental | Drug: Tasimelteon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension | Drug | Once Daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep time over the treatment period, as measured by sleep diary. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires. | 12 weeks | |
| Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Contact | 202-734-3400 | VEC162@vandapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Recruiting | San Jose | California | 95124 | United States |
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| 12 weeks |
| Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). | 12 weeks |
| Vanda Investigational Site | Recruiting | San Leandro | California | 94578 | United States |
|
| Vanda Investigational Site | Recruiting | Santa Monica | California | 90404 | United States |
|
| Vanda Investigational Site | Recruiting | Boulder | Colorado | 80301 | United States |
|
| Vanda Investigational Site | Recruiting | Staten Island | New York | 10312 | United States |
|
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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