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This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasimelteon | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon | Drug | Oral capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Latency to Persistent Sleep, as measured by polysomnography. | Two Nights |
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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 | Çankaya | Ankara | 06800 | Turkey (Türkiye) |
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| Drug |
Oral capsule |
|
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D020178 | Sleep Disorders, Circadian Rhythm |
| D021081 | Chronobiology Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
| D009784 | Occupational Diseases |
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| ID | Term |
|---|---|
| C478745 | tasimelteon |
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