Trial record 2 of 22 for:
VEC-162
VEC-162 Study in Adult Patients With Primary Insomnia
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00548340 |
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Recruitment Status :
Completed
First Posted : October 23, 2007
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
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Sponsor:
Vanda Pharmaceuticals
Information provided by (Responsible Party):
Vanda Pharmaceuticals
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Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Primary Insomnia | Drug: VEC-162 20 mg Drug: Placebo Drug: VEC-162 50 mg | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 322 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 (20 mg/Day and 50 mg/Day) in the Treatment of Primary Insomnia |
| Study Start Date : | November 2007 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | June 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: VEC-162 20 mg
VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
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Drug: VEC-162 20 mg
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks |
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Experimental: VEC-162 50 mg
VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
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Drug: VEC-162 50 mg
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks |
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Placebo Comparator: Placebo
Placebo capsules PO daily five weeks
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Drug: Placebo
Placebo capsules, PO daily for five weeks |
Primary Outcome Measures :
- Average Change From Baseline - Latency to Persistent Sleep (LPS) [ Time Frame: Baseline, Night 1, and Night 8 measurement ]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.
Secondary Outcome Measures :
- Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) [ Time Frame: Baseline, Night 1, and Night 8 measurements for WASO and 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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| Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females with a diagnosis of primary insomnia as defined in DSM-IV.
- Habitual bedtime between 9:00 pm and 1:00 am.
- No history or evidence of restless leg syndrome or periodic limb movement disorder or sleep apnea.
- Patients must sign a written consent form.
Exclusion Criteria:
- History of drug or alcohol abuse as defined in DSM-IV.
- History of psychiatric disorders, including Major Depressive Disorder, Generalized Anxiety Disorder and delirium.
- History of chronic obstructive pulmonary disease (COPD), seizures, sleep apnea, narcolepsy, circadian-rhythm sleep disorder, parasomnia or any sleep disorder other than chronic insomnia.
- Recent history of shift work or jet lag.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548340
Locations
| United States, Alabama | |
| Vanda Investigational Site | |
| Birmingham, Alabama, United States | |
| United States, Arkansas | |
| Vanda Investigational Site | |
| Hot Springs, Arkansas, United States | |
| Vanda Investigational Site | |
| Little Rock, Arkansas, United States | |
| United States, California | |
| 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 | |
| United States, Colorado | |
| Vanda Investigational Site | |
| Colorado Springs, Colorado, United States | |
| United States, Florida | |
| Vanda Investigational Site | |
| Hallandale Beach, 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 | |
| United States, Georgia | |
| Vanda Investigational Site | |
| Atlanta, Georgia, United States | |
| United States, Illinois | |
| Vanda Investigational Site | |
| Chicago, Illinois, United States | |
| United States, Kansas | |
| Vanda Investigational Site | |
| Overland Park, Kansas, United States | |
| United States, Kentucky | |
| Vanda Investigational Site | |
| Crestview Hills, Kentucky, United States | |
| Vanda Investigational Site | |
| Lexington, Kentucky, United States | |
| Vanda Investigational Site | |
| Louisville, Kentucky, United States | |
| United States, Maryland | |
| Vanda Investigational Site | |
| Chevy Chase, Maryland, United States | |
| United States, Massachusetts | |
| Vanda Investigational Site | |
| Newton, Massachusetts, United States | |
| United States, Michigan | |
| Vanda Investigational Site | |
| Troy, Michigan, United States | |
| United States, Missouri | |
| Vanda Investigational Site | |
| Chesterfield, Missouri, United States | |
| United States, Nevada | |
| Vanda Investigational Site | |
| Las Vegas, Nevada, United States | |
| United States, New York | |
| Vanda Investigational Site | |
| New York, New York, United States | |
| Vanda Investigational Site | |
| West Seneca, New York, United States | |
| United States, North Carolina | |
| Vanda Investigational Site | |
| Raleigh, North Carolina, United States | |
| United States, Ohio | |
| Vanda Investigational Site | |
| Beachwood, Ohio, United States | |
| Vanda Investigational Site | |
| Cincinnati, Ohio, United States | |
| United States, Oklahoma | |
| Vanda Investigational Site | |
| Oklahoma City, Oklahoma, United States | |
| United States, South Carolina | |
| Vanda Investigational Site | |
| Columbia, South Carolina, United States | |
| United States, Texas | |
| Vanda Investigational Site | |
| Austin, Texas, United States | |
| Vanda Investigational Site | |
| Dallas, Texas, United States | |
Sponsors and Collaborators
Vanda Pharmaceuticals
| Responsible Party: | Vanda Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00548340 |
| Other Study ID Numbers: |
VP-VEC-162-3104 |
| First Posted: | October 23, 2007 Key Record Dates |
| Results First Posted: | October 15, 2014 |
| Last Update Posted: | October 15, 2014 |
| Last Verified: | October 2014 |
Additional relevant MeSH terms:
|
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias |
Sleep Wake Disorders Nervous System Diseases Mental Disorders |