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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 pediatric participants with insomnia disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tasimelteon | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasimelteon Oral Suspension | Drug | Single daily dose, weight-based liquid suspension formulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in sleep latency, as measured by daily sleep diary. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary. | 12 Weeks | |
| Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary. | 12 Weeks |
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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 | Dothan | Alabama | 36303 | United States |
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| Placebo | Drug | Placebo comparator. |
|
| Change in daytime functioning, as measured by questionnaire. | 12 Weeks |
| Change in behavior, as measured by questionnaire. | 12 Weeks |
| Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy. | 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 | Phoenix | Arizona | 85006 | United States |
|
| Vanda Investigational Site | Recruiting | Irvine | California | 92614 | United States |
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| Vanda Investigational Site | Recruiting | Miami | Florida | 33155 | United States |
|
| Vanda Investigational Site | Recruiting | Miami Lakes | Florida | 33016 | United States |
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| Vanda Investigational Site | Recruiting | Winter Park | Florida | 32789 | United States |
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| Vanda Investigational Site | Recruiting | Snellville | Georgia | 30078 | United States |
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| Vanda Investigational Site | Recruiting | Stockbridge | Georgia | 30281 | United States |
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| Vanda Investigational Site | Recruiting | Naperville | Illinois | 60563 | United States |
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| Vanda Investigational Site | Recruiting | Worcester | Massachusetts | 01608 | United States |
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| Vanda Investigational Site | Recruiting | Great Falls | Montana | 59405 | United States |
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| Vanda Investigational Site | Active, not recruiting | Lincoln | Nebraska | 68526 | United States |
| Vanda Investigational Site | Recruiting | Las Vegas | Nevada | 89128 | United States |
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| Vanda Investigational Site | Recruiting | Cleveland | Ohio | 11100 | United States |
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| Vanda Investigational Site | Recruiting | Columbia | South Carolina | 29201 | United States |
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| Vanda Investigational Site | Recruiting | Myrtle Beach | South Carolina | 29582 | United States |
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| Vanda Investigational Site | Recruiting | Nashville | Tennessee | 37232 | United States |
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| Vanda Investigational Site | Recruiting | Houston | Texas | 77030 | United States |
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| Vanda Investigational Site | Recruiting | Plano | Texas | 75075 | United States |
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| Vanda Investigational Site | Recruiting | San Antonio | Texas | 78229 | United States |
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| Vanda Investigational Site | Recruiting | San Antonio | Texas | 78249 | United States |
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| Vanda Investigational Site | Recruiting | Berlin | 10117 | Germany |
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| Vanda Investigational Site | Recruiting | Leipzig | 04177 | Germany |
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| Vanda Investigational Site | Recruiting | Bydgoszcz | 85-092 | Poland |
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| Vanda Investigational Site | Recruiting | Gdansk | 80-546 | Poland |
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| Vanda Investigational Site | Recruiting | Krakow | 30-721 | Poland |
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| Vanda Investigational Site | Recruiting | Poznan | 60-848 | Poland |
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| Vanda Investigational Site | Recruiting | Wroclaw | 50-414 | Poland |
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| Vanda Investigational Site | Recruiting | Great Yarmouth | NR31 6LA | United Kingdom |
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| Vanda Investigational Site | Recruiting | Leicester | LE1 5WW | United Kingdom |
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| Vanda Investigational Site | Recruiting | Liverpool | L12 2AP | United Kingdom |
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| Vanda Investigational Site | Recruiting | London | E1 1FR | United Kingdom |
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| Vanda Investigational Site | Recruiting | London | SE1 7EH | United Kingdom |
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| Vanda Investigational Site | Recruiting | London | SE6 4LF | United Kingdom |
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| Vanda Investigational Site | Recruiting | Sheffield | S10 2TH | United Kingdom |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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