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This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female participants with DSWPD.
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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 |
|---|---|---|
| Change in Sleep Onset over the treatment period, as measured by sleep diary. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nighttime objective sleep-wake parameters such as sleep time, as measured by actigraphy. | 28 days | |
| Change in nighttime subjective sleep-wake parameters such as sleep time, as measured by sleep diary. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Contact | 202-734-3400 | clinicaltrials@vandapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Recruiting | Los Angeles | California | 90025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38033548 | Derived | Smieszek SP, Kaden AR, Johnson CE, Brzezynski JL, Xiao C, Polymeropoulos CM, Birznieks G, Emsellem HA, Polymeropoulos MH. Case report: A patient with Delayed Sleep-Wake Phase Disorder and Optic Nerve Hypoplasia treated with tasimelteon: a case study. Front Neurosci. 2023 Nov 14;17:1287514. doi: 10.3389/fnins.2023.1287514. eCollection 2023. |
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| Drug |
oral capsule |
|
| Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). | 28 days |
| Vanda Investigational Site | Recruiting | Redwood City | California | 94063 | United States |
|
| Vanda Investigational Site | Recruiting | Aurora | Colorado | 80045 | United States |
|
| Vanda Investigational Site | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Vanda Investigational Site | Recruiting | St Louis | Missouri | 63123 | United States |
|
| Vanda Investigational Site | Recruiting | New Hyde Park | New York | 11042 | United States |
|
| Vanda Investigational Site | Recruiting | Cincinnati | Ohio | 45212 | United States |
|
| Vanda Investigational Site | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Vanda Investigational Site | Recruiting | Columbia | South Carolina | 29201 | United States |
|
| Vanda Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Vanda Investigational Site | Recruiting | Sherman | Texas | 75092 | United States |
|
| Vanda Investigational Site | Active, not recruiting | Innsbruck | 6020 | Austria |
| Vanda Investigational Site | Recruiting | Vienna | 1090 | Austria |
|
| Vanda Investigational Site | Recruiting | Berlin | 10117 | Germany |
|
| Vanda Investigational Site | Recruiting | Hamburg | 20253 | Germany |
|
| Vanda Investigational Site | Recruiting | Marburg | 35043 | Germany |
|
| Vanda Investigational Site | Recruiting | Schwerin | 19053 | Germany |
|
| 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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