A Phase 3 interventional study of VEC-162 20 mg and Placebo in Primary Insomnia, sponsored by Vanda Pharmaceuticals. Completed at 35 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-10-15.
Sponsored by Vanda Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 322 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
VEC-162 (tasimelteon) 20 mg capsules PO daily for five weeks
Drug: VEC-162 20 mg
VEC-162 (tasimelteon) 50 mg capsules PO daily for five weeks
Drug: VEC-162 50 mg
Placebo capsules PO daily five weeks
Drug: Placebo
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Placebo capsules, PO daily for five weeks
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
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.
Time frame: Baseline, Night 1, and Night 8 measurement
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.
Time frame: Baseline, Night 1, and Night 8 measurements for WASO and TST
| Milestone | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| Started | 109 | 109 | 104 |
| Completed | 101 | 98 | 95 |
| Not completed | 8 | 11 | 9 |
| Withdrew: Protocol violation | 2 | 3 | 3 |
| Withdrew: Adverse event | 2 | 2 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 2 | 4 | 3 |
| Withdrew: Other | 1 | 1 | 1 |
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.
| minutes | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| Average Change From Baseline - Latency to Persistent Sleep (LPS) | 45.0 ± 2.965 | 46.4 ± 2.954 | 28.3 ± 3.020 |
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.
| minutes | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| Avg WASO Change from Baseline | 12.2 ± 4.349 | 14.1 ± 4.329 | 11.7 ± 4.569 |
| Avg TST Change from Baseline | 51.4 ± 4.794 | 52.0 ± 4.775 | 39.9 ± 4.882 |
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.
| minutes | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| Average Change From Baseline - Latency to Persistent Sleep (LPS) | 49.4 ± 3.309 | 45.1 ± 3.292 | 33.9 ± 3.338 |
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.
| minutes | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| Avg WASO Change from Baseline | 17.7 ± 4.139 | 10.2 ± 4.184 | 20.3 ± 4.381 |
| Avg TST Change from Baseline | 60.3 ± 4.821 | 48.6 ± 4.802 | 47.4 ± 4.882 |
Collected over Night 1 to Day 37 (EOS). Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VEC-162 20 mg | — | 1/109 (0.9%) | 15/109 (13.8%) |
| VEC-162 50 mg | — | 0/109 (0%) | 13/109 (11.9%) |
| Placebo | — | 1/104 (1%) | 11/109 (10.1%) |
| Event | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| Hypertensive EmergencyVascular disorders | 0/109 | 0/109 | 1/104 |
| Blood Pressure IncreasedInvestigations | 1/109 | 0/109 | 0/104 |
| Event | VEC-162 20 mg | VEC-162 50 mg | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 11/109 | 4/109 | 5/109 |
| Blood Creatine Phosphokinase IncreasedInvestigations | 0/109 | 5/109 | 2/109 |
| NasopharyngitisInfections and infestations | 3/109 | 4/109 | 4/109 |
| Urinary Tract InfectionInfections and infestations | 4/109 | 2/109 | 1/109 |
| Age, Continuous(years) | VEC-162 20 mg | VEC-162 50 mg | Placebo | Total |
|---|---|---|---|---|
| Mean | 42.9 ± 10.6 | 40.7 ± 10.4 | 41.7 ± 11.8 | 41.8 ± 10.9 |
| Age, Categorical(Participants) | VEC-162 20 mg | VEC-162 50 mg | Placebo | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 109 | 109 | 104 | 322 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | VEC-162 20 mg | VEC-162 50 mg | Placebo | Total |
|---|---|---|---|---|
| Female | 66 | 63 | 68 | 197 |
| Male | 43 | 46 | 36 | 125 |
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Vanda Pharmaceuticals