Primary Insomnia
Conditions
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.
Interventions
DRUGVEC-162 20 mg
20 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
DRUGPlacebo
Placebo capsules, PO daily for five weeks
DRUGVEC-162 50 mg
50 mg VEC-162 (tasimelteon) capsules, PO daily for five weeks
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline - Latency to Persistent Sleep (LPS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VEC-162 20 mg VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks | 109 |
| VEC-162 50 mg VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks | 109 |
| Placebo Placebo: Placebo capsules, PO daily for five weeks | 104 |
| Total | 322 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Other | 1 | 1 | 1 |
| Overall Study | Protocol Violation | 2 | 3 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 3 |
Baseline characteristics
| Characteristic | Placebo | VEC-162 50 mg | VEC-162 20 mg | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 104 Participants | 109 Participants | 109 Participants | 322 Participants |
| Age, Continuous | 41.7 years STANDARD_DEVIATION 11.8 | 40.7 years STANDARD_DEVIATION 10.4 | 42.9 years STANDARD_DEVIATION 10.6 | 41.8 years STANDARD_DEVIATION 10.9 |
| Sex: Female, Male Female | 68 Participants | 63 Participants | 66 Participants | 197 Participants |
| Sex: Female, Male Male | 36 Participants | 46 Participants | 43 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 15 / 109 | 13 / 109 | 11 / 109 |
| serious Total, serious adverse events | 1 / 109 | 0 / 109 | 1 / 104 |
Outcome results
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.
Time frame: Baseline, Night 1, and Night 8 measurement
Population: One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VEC-162 20 mg | Average Change From Baseline - Latency to Persistent Sleep (LPS) | 45.0 minutes | Standard Error 2.965 |
| VEC-162 50 mg | Average Change From Baseline - Latency to Persistent Sleep (LPS) | 46.4 minutes | Standard Error 2.954 |
| Placebo | Average Change From Baseline - Latency to Persistent Sleep (LPS) | 28.3 minutes | Standard Error 3.02 |
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.
Time frame: Baseline, Night 1, and Night 8 measurements for WASO and TST
Population: One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VEC-162 20 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg WASO Change from Baseline | 12.2 minutes | Standard Error 4.349 |
| VEC-162 20 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg TST Change from Baseline | 51.4 minutes | Standard Error 4.794 |
| VEC-162 50 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg WASO Change from Baseline | 14.1 minutes | Standard Error 4.329 |
| VEC-162 50 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg TST Change from Baseline | 52.0 minutes | Standard Error 4.775 |
| Placebo | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg WASO Change from Baseline | 11.7 minutes | Standard Error 4.569 |
| Placebo | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg TST Change from Baseline | 39.9 minutes | Standard Error 4.882 |
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.
Time frame: Baseline, Night 22, and Night 29 measurement
Population: One subject randomized to VEC-162 20 mg did not have any post-baseline PSG data and was excluded from the Full Analysis Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VEC-162 20 mg | Average Change From Baseline - Latency to Persistent Sleep (LPS) | 49.4 minutes | Standard Error 3.309 |
| VEC-162 50 mg | Average Change From Baseline - Latency to Persistent Sleep (LPS) | 45.1 minutes | Standard Error 3.292 |
| Placebo | Average Change From Baseline - Latency to Persistent Sleep (LPS) | 33.9 minutes | Standard Error 3.338 |
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.
Time frame: Baseline, Night 22, and Night 29 measurements for WASO and TST
Population: One subject randomized to VEC-162 20 mg did not have post-baseline PSG data and was excluded from the Full Analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| VEC-162 20 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg WASO Change from Baseline | 17.7 minutes | Standard Error 4.139 |
| VEC-162 20 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg TST Change from Baseline | 60.3 minutes | Standard Error 4.821 |
| VEC-162 50 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg WASO Change from Baseline | 10.2 minutes | Standard Error 4.184 |
| VEC-162 50 mg | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg TST Change from Baseline | 48.6 minutes | Standard Error 4.802 |
| Placebo | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg WASO Change from Baseline | 20.3 minutes | Standard Error 4.381 |
| Placebo | Average Change From Baseline - Wake After Sleep Onset (WASO) and Total Sleep Time (TST) | Avg TST Change from Baseline | 47.4 minutes | Standard Error 4.882 |