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VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study to Investigate the Efficacy and Safety of VEC-162 and Matching Placebo in Healthy Male and Female Subjects With Induced Transient Insomnia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00291187
Enrollment
411
Registered
2006-02-13
Start date
2006-02-28
Completion date
2006-08-31
Last updated
2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Brief summary

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.

Interventions

DRUG20 mg VEC-162

20 mg VEC-162

DRUG50 mg VEC-162

50 mg VEC-162

DRUG100 mg VEC-162

100 mg VEC-162

DRUGPlacebo

Placebo

Sponsors

Vanda Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy subjects with no medical, psychiatric or current sleep disorders. * Subject must sign a written consent form.

Exclusion criteria

* Recent history of night shift work or jet lag. * Prior experience sleeping in a sleep lab environment. * History of sleep disorders.

Design outcomes

Primary

MeasureTime frameDescription
Average Improvement of Latency to Persistent Sleep (LPS)Night 1The 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.

Secondary

MeasureTime frameDescription
Average Improvement of Wake After Sleep Onset (WASO)Night 1The 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Placebo
Taken orally 30 minutes prior to bedtime.
103
VEC-162 20 mg
20 mg taken orally 30 minutes prior to bedtime.
100
VEC-162 50 mg
50 mg taken orally 30 minutes prior to bedtime.
102
VEC-162 100 mg
100 mg taken orally 30 minutes prior to bedtime.
106
Total411

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyProtocol Violation- No Drug Administered0010

Baseline characteristics

CharacteristicTotalPlaceboVEC-162 20 mgVEC-162 50 mgVEC-162 100 mg
Age, Continuous31.0 years
STANDARD_DEVIATION 8.08
30.9 years
STANDARD_DEVIATION 7.28
30.8 years
STANDARD_DEVIATION 8.41
31.0 years
STANDARD_DEVIATION 8.51
31.2 years
STANDARD_DEVIATION 8.19
Sex: Female, Male
Female
261 Participants68 Participants62 Participants58 Participants73 Participants
Sex: Female, Male
Male
150 Participants35 Participants38 Participants44 Participants33 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
5 / 1037 / 1005 / 1026 / 106
serious
Total, serious adverse events
0 / 1030 / 1000 / 1020 / 106

Outcome results

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.

Time frame: Night 1

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboAverage Improvement of Latency to Persistent Sleep (LPS)45.8 minutesStandard Error 4.28
VEC-162 20 mgAverage Improvement of Latency to Persistent Sleep (LPS)24.3 minutesStandard Error 4.35
VEC-162 50 mgAverage Improvement of Latency to Persistent Sleep (LPS)19.6 minutesStandard Error 4.31
VEC-162 100 mgAverage Improvement of Latency to Persistent Sleep (LPS)23.1 minutesStandard Error 4.21
p-value: <0.00195% CI: [-33.1, -9.9]ANCOVA
p-value: <0.00195% CI: [-37.8, -14.7]ANCOVA
p-value: <0.00195% CI: [-34.2, -11.3]ANCOVA
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.

Time frame: Night 1

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboAverage Improvement of Wake After Sleep Onset (WASO)139.3 minutesStandard Error 7.33
VEC-162 20 mgAverage Improvement of Wake After Sleep Onset (WASO)115.1 minutesStandard Error 7.46
VEC-162 50 mgAverage Improvement of Wake After Sleep Onset (WASO)105.6 minutesStandard Error 7.39
VEC-162 100 mgAverage Improvement of Wake After Sleep Onset (WASO)121.9 minutesStandard Error 7.22
p-value: 0.01795% CI: [-44.1, -4.3]ANCOVA
p-value: 0.00195% CI: [-53.6, -13.9]ANCOVA
p-value: 0.08195% CI: [-37, 2.1]ANCOVA
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.

Time frame: Night 1

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboAverage Improvement in Latency to Non-awake (LNA)22.3 MinutesStandard Error 2.88
VEC-162 20 mgAverage Improvement in Latency to Non-awake (LNA)11.2 MinutesStandard Error 2.93
VEC-162 50 mgAverage Improvement in Latency to Non-awake (LNA)8.0 MinutesStandard Error 2.9
VEC-162 100 mgAverage Improvement in Latency to Non-awake (LNA)10.0 MinutesStandard Error 2.84
p-value: 0.00695% CI: [-18.9, -3.3]ANCOVA
p-value: <0.00195% CI: [-22.1, -6.5]ANCOVA
p-value: 0.00295% CI: [-20, -4.6]ANCOVA
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.

Time frame: Night 1

Population: 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.

ArmMeasureValue (MEAN)Dispersion
PlaceboAverage Improvement in Total Sleep Time (TST)317.6 MinutesStandard Error 7.65
VEC-162 20 mgAverage Improvement in Total Sleep Time (TST)351.4 MinutesStandard Error 7.78
VEC-162 50 mgAverage Improvement in Total Sleep Time (TST)365.5 MinutesStandard Error 7.71
VEC-162 100 mgAverage Improvement in Total Sleep Time (TST)347.2 MinutesStandard Error 7.53
p-value: 0.00295% CI: [13, 54.5]ANCOVA
p-value: <0.00195% CI: [27.2, 68.6]ANCOVA
p-value: 0.00595% CI: [9.1, 50]ANCOVA

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026