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The purpose of this study is to evaluate the efficacy and safety of a 5 week double-blind treatment period of VEC-162 as compared to placebo in male and female patients with primary insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VEC-162 20 mg | Experimental | VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks |
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| VEC-162 50 mg | Experimental | VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks |
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| Placebo | Placebo Comparator | Placebo capsules PO daily five weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEC-162 20 mg | Drug | 20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline - Latency to Persistent Sleep (LPS) | Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8. | Baseline, Night 1, and Night 8 measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Birmingham | Alabama | United States | |||
| Vanda Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | VEC-162 20 mg | VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks |
| FG001 | VEC-162 50 mg | VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Placebo capsules, PO daily for five weeks |
|
| VEC-162 50 mg | Drug | 50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks |
|
| Baseline, Night 1, and Night 8 measurements for WASO and TST |
| Hot Springs |
| Arkansas |
| United States |
| Vanda Investigational Site | Little Rock | Arkansas | United States |
| Vanda Investigational Site | Anaheim | California | United States |
| Vanda Investigational Site | Burbank | California | United States |
| Vanda Investigational Site | Los Angeles | California | United States |
| Vanda Investigational Site | San Diego | California | United States |
| Vanda Investigational Site | Santa Monica | California | United States |
| Vanda Investigational Site | Colorado Springs | Colorado | United States |
| Vanda Investigational Site | Hallandale | Florida | United States |
| Vanda Investigational Site | Miami | Florida | United States |
| Vanda Investigational Site | Naples | Florida | United States |
| Vanda Investigational Site | Orlando | Florida | United States |
| Vanda Investigational Site | Pembroke Pines | Florida | United States |
| Vanda Investigational Site | St. Petersburg | Florida | United States |
| Vanda Investigational Site | Atlanta | Georgia | United States |
| Vanda Investigational Site | Chicago | Illinois | United States |
| Vanda Investigational Site | Overland Park | Kansas | United States |
| Vanda Investigational Site | Crestview Hills | Kentucky | United States |
| Vanda Investigational Site | Lexington | Kentucky | United States |
| Vanda Investigational Site | Louisville | Kentucky | United States |
| Vanda Investigational Site | Chevy Chase | Maryland | United States |
| Vanda Investigational Site | Newton | Massachusetts | United States |
| Vanda Investigational Site | Troy | Michigan | United States |
| Vanda Investigational Site | Chesterfield | Missouri | United States |
| Vanda Investigational Site | Las Vegas | Nevada | United States |
| Vanda Investigational Site | New York | New York | United States |
| Vanda Investigational Site | West Seneca | New York | United States |
| Vanda Investigational Site | Raleigh | North Carolina | United States |
| Vanda Investigational Site | Beachwood | Ohio | United States |
| Vanda Investigational Site | Cincinnati | Ohio | United States |
| Vanda Investigational Site | Oklahoma City | Oklahoma | United States |
| Vanda Investigational Site | Columbia | South Carolina | United States |
| Vanda Investigational Site | Austin | Texas | United States |
| Vanda Investigational Site | Dallas | Texas | United States |
| FG002 | Placebo | Placebo: Placebo capsules, PO daily for five weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VEC-162 20 mg | VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks |
| BG001 | VEC-162 50 mg | VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks |
| BG002 | Placebo | Placebo: Placebo capsules, PO daily for five weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Average Change From Baseline - Latency to Persistent Sleep (LPS) | Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point at which 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline and the average of nights 1 and 8. | One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population. | Posted | Mean | Standard Error | minutes | Baseline, Night 1, and Night 8 measurement |
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| Secondary | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 1 and 8. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 1 and 8. | One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population. | Posted | Mean | Standard Error | minutes | Baseline, Night 1, and Night 8 measurements for WASO and TST |
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| Post-Hoc | Average Change From Baseline - Latency to Persistent Sleep (LPS) | Average latency to persistent sleep is defined as the length of time elapsed between lights off and onset of persistent sleep (defined as the point 10 minutes of uninterrupted sleep has begun as determined by PSG) between Baseline, and the average of nights 22 and 29. | One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population. | Posted | Mean | Standard Error | minutes | Baseline, Night 22, and Night 29 measurement |
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| Post-Hoc | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Average wake after sleep onset was defined as the time spent awake between onset of sleep (latency to non-awake) and lights-on, as determined by PSG between Baseline, and the average of nights 22 and 29. Total sleep time (TST) was defined as the time spent sleeping between lights-out and lights-on, i.e., full night between Baseline, and the average of nights 22 and 29. | One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population. | Posted | Mean | Standard Error | minutes | Baseline, Night 22, and Night 29 measurements for WASO and TST |
|
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Night 1 to Day 37 (EOS)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VEC-162 20 mg | VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks | 1 | 109 | 15 | 109 | ||
| EG001 | VEC-162 50 mg | VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks | 0 | 109 | 13 | 109 | ||
| EG002 | Placebo | Placebo: Placebo capsules, PO daily for five weeks | 1 | 104 | 11 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertensive Emergency | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (10.1) | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlene Dressman, Ph.D. | Vanda Pharmaceuticals Inc. | 202-734-3462 | marlene.dressman@vandapharma.com |
| 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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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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