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The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Take orally 30 minutes prior to bedtime. |
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| 20 mg VEC-162 | Experimental | 20 mg taken orally 30 minutes prior to bedtime. |
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| 50 mg VEC-162 | Experimental | 50 mg taken orally 30 minutes prior to bedtime. |
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| 100 mg VEC-162 | Experimental | 100 mg taken orally 30 minutes prior to bedtime. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mg VEC-162 | Drug | 20 mg VEC-162 |
| |
| 50 mg VEC-162 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Improvement of Latency to Persistent Sleep (LPS) | The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Night 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Improvement of Wake After Sleep Onset (WASO) | The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Night 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanda Pharmaceuticals | Vanda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Birmingham | Alabama | United States | |||
| Vanda Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19054552 | Derived | Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C, Birznieks G, Klerman EB. Melatonin agonist tasimelteon (VEC-162) for transient insomnia after sleep-time shift: two randomised controlled multicentre trials. Lancet. 2009 Feb 7;373(9662):482-91. doi: 10.1016/S0140-6736(08)61812-7. Epub 2008 Dec 4. |
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Prior to treatment assignment, subjects were instructed to start a sleep schedule that required staying in bed and trying to sleep for at least 8 hours per night.
One subject randomized to VEC-162 50 mg was non-compliant for sleep schedule. Subject was discontinued on Day 1 prior to study drug administration.
Recruitment took place at 20 US sites. The first subject was screened on February 9th 2006, the first subject enrolled on March 10th, 2006, and the last subject completed on August 21st 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | taken orally 30 minutes prior to bedtime |
| FG001 | VEC-162 20 mg | 20 mg taken orally 30 minutes prior to bedtime |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
50 mg VEC-162 |
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| 100 mg VEC-162 | Drug | 100 mg VEC-162 |
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| Placebo | Drug | Placebo |
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| Phoenix |
| Arizona |
| United States |
| Vanda Investigational Site | San Diego | California | United States |
| Vanda Investigational Site | San Francisco | California | United States |
| Vanda Investigational Site | Santa Monica | California | United States |
| Vanda Investigational Site | Miami | Florida | United States |
| Vanda Investigational Site | Naples | 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 | Overland Park | Kansas | United States |
| Vanda Investigational Site | Chevy Chase | Maryland | United States |
| Vanda Investigational Site | New York | New York | United States |
| Vanda Investigational Site | Rochester | New York | United States |
| Vanda Investigational Site | Raleigh | North Carolina | United States |
| Vanda Investigational Site | Cincinnati | Ohio | United States |
| Vanda Investigational Site | Columbia | South Carolina | United States |
| Vanda Investigational Site | Austin | Texas | United States |
| Vanda Investigational Site | Plano | Texas | United States |
| FG002 | VEC-162 50 mg | 50 mg taken orally 30 minutes prior to bedtime |
| FG003 | VEC-162 100 mg | 100 mg taken orally 30 minutes prior to bedtime |
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| NOT COMPLETED |
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Modified Intent-to-Treat. A total of 411 subjects received treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Taken orally 30 minutes prior to bedtime. |
| BG001 | VEC-162 20 mg | 20 mg taken orally 30 minutes prior to bedtime. |
| BG002 | VEC-162 50 mg | 50 mg taken orally 30 minutes prior to bedtime. |
| BG003 | VEC-162 100 mg | 100 mg taken orally 30 minutes prior to bedtime. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| 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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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Average Improvement of Latency to Persistent Sleep (LPS) | The average improvement in Latency to persistent sleep (the number of minutes between Lights Off and the onset of at least 10 minutes of persistent sleep, as measured by polysomnography) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored. | Posted | Mean | Standard Error | minutes | Night 1 |
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| Secondary | Average Improvement of Wake After Sleep Onset (WASO) | The average improvement of wake after sleep onset (time spent awake between onset of sleep and lights on, determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored. | Posted | Mean | Standard Error | minutes | Night 1 |
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| Post-Hoc | Average Improvement in Total Sleep Time (TST) | The average improvement in Total sleep time (determined by PSG and defined as the number of non-wake minutes between lights off and lights on) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored. | Posted | Mean | Standard Error | Minutes | Night 1 |
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| Post-Hoc | Average Improvement in Latency to Non-awake (LNA) | The average improvement in latency to non-awake (length of time elapsed between lights off and first epoch of sleep determined by PSG) is defined as the difference observed in the VEC-162 treated subjects compared with placebo treated subjects. | Modified ITT defined as any subject randomized into the study who received a dose of study drug and had PSG data. For the purposes of this trial, a subject was considered to have PSG data if 50% or more of the full night PSG was scored. | Posted | Mean | Standard Error | Minutes | Night 1 |
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Day 1 through Day 2.
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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 | Placebo | Taken orally 30 minutes prior to bedtime. | 0 | 103 | 5 | 103 | ||
| EG001 | VEC-162 20 mg | 20 mg taken orally 30 minutes prior to bedtime. | 0 | 100 | 7 | 100 | ||
| EG002 | VEC-162 50 mg | 50 mg taken orally 30 minutes prior to bedtime. | 0 | 102 | 5 | 102 | ||
| EG003 | VEC-162 100 mg | 100 mg taken orally 30 minutes prior to bedtime. | 0 | 106 | 6 | 106 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Abnormal Dreams | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
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| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlene Dressman, PhD. | 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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| Male |
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| Mean Difference (Final Values) |
| -26.3 |
| 2-Sided |
| 95 |
| -37.8 |
| -14.7 |
| No |
| Superiority or Other |
| ANCOVA | <0.001 | Mean Difference (Final Values) | -22.8 | 2-Sided | 95 | -34.2 | -11.3 | No | Superiority or Other |
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