Trial Outcomes & Findings for VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia (NCT NCT00291187)
NCT ID: NCT00291187
Last Updated: 2014-10-15
Results Overview
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.
COMPLETED
PHASE3
411 participants
Night 1
2014-10-15
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
taken orally 30 minutes prior to bedtime
|
VEC-162 20 mg
20 mg taken orally 30 minutes prior to bedtime
|
VEC-162 50 mg
50 mg taken orally 30 minutes prior to bedtime
|
VEC-162 100 mg
100 mg taken orally 30 minutes prior to bedtime
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
103
|
100
|
103
|
106
|
|
Overall Study
COMPLETED
|
103
|
100
|
102
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo
taken orally 30 minutes prior to bedtime
|
VEC-162 20 mg
20 mg taken orally 30 minutes prior to bedtime
|
VEC-162 50 mg
50 mg taken orally 30 minutes prior to bedtime
|
VEC-162 100 mg
100 mg taken orally 30 minutes prior to bedtime
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation- No Drug Administered
|
0
|
0
|
1
|
0
|
Baseline Characteristics
VEC-162 Study in Healthy Adult Volunteers in a Model of Insomnia
Baseline characteristics by cohort
| Measure |
Placebo
n=103 Participants
Taken orally 30 minutes prior to bedtime.
|
VEC-162 20 mg
n=100 Participants
20 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 50 mg
n=102 Participants
50 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 100 mg
n=106 Participants
100 mg taken orally 30 minutes prior to bedtime.
|
Total
n=411 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 7.28 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 8.41 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 8.51 • n=5 Participants
|
31.2 years
STANDARD_DEVIATION 8.19 • n=4 Participants
|
31.0 years
STANDARD_DEVIATION 8.08 • n=21 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
261 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
150 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Night 1Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=103 Participants
Taken orally 30 minutes prior to bedtime.
|
VEC-162 20 mg
n=100 Participants
20 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 50 mg
n=102 Participants
50 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 100 mg
n=106 Participants
100 mg taken orally 30 minutes prior to bedtime.
|
|---|---|---|---|---|
|
Average Improvement of Latency to Persistent Sleep (LPS)
|
45.8 minutes
Standard Error 4.28
|
24.3 minutes
Standard Error 4.35
|
19.6 minutes
Standard Error 4.31
|
23.1 minutes
Standard Error 4.21
|
SECONDARY outcome
Timeframe: Night 1Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=103 Participants
Taken orally 30 minutes prior to bedtime.
|
VEC-162 20 mg
n=100 Participants
20 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 50 mg
n=102 Participants
50 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 100 mg
n=106 Participants
100 mg taken orally 30 minutes prior to bedtime.
|
|---|---|---|---|---|
|
Average Improvement of Wake After Sleep Onset (WASO)
|
139.3 minutes
Standard Error 7.33
|
115.1 minutes
Standard Error 7.46
|
105.6 minutes
Standard Error 7.39
|
121.9 minutes
Standard Error 7.22
|
POST_HOC outcome
Timeframe: Night 1Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=103 Participants
Taken orally 30 minutes prior to bedtime.
|
VEC-162 20 mg
n=100 Participants
20 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 50 mg
n=102 Participants
50 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 100 mg
n=106 Participants
100 mg taken orally 30 minutes prior to bedtime.
|
|---|---|---|---|---|
|
Average Improvement in Total Sleep Time (TST)
|
317.6 Minutes
Standard Error 7.65
|
351.4 Minutes
Standard Error 7.78
|
365.5 Minutes
Standard Error 7.71
|
347.2 Minutes
Standard Error 7.53
|
POST_HOC outcome
Timeframe: Night 1Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=103 Participants
Taken orally 30 minutes prior to bedtime.
|
VEC-162 20 mg
n=100 Participants
20 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 50 mg
n=102 Participants
50 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 100 mg
n=106 Participants
100 mg taken orally 30 minutes prior to bedtime.
|
|---|---|---|---|---|
|
Average Improvement in Latency to Non-awake (LNA)
|
22.3 Minutes
Standard Error 2.88
|
11.2 Minutes
Standard Error 2.93
|
8.0 Minutes
Standard Error 2.90
|
10.0 Minutes
Standard Error 2.84
|
Adverse Events
Placebo
VEC-162 20 mg
VEC-162 50 mg
VEC-162 100 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=103 participants at risk
Taken orally 30 minutes prior to bedtime.
|
VEC-162 20 mg
n=100 participants at risk
20 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 50 mg
n=102 participants at risk
50 mg taken orally 30 minutes prior to bedtime.
|
VEC-162 100 mg
n=106 participants at risk
100 mg taken orally 30 minutes prior to bedtime.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/103 • Number of events 3 • Day 1 through Day 2.
|
3.0%
3/100 • Number of events 3 • Day 1 through Day 2.
|
2.9%
3/102 • Number of events 3 • Day 1 through Day 2.
|
2.8%
3/106 • Number of events 3 • Day 1 through Day 2.
|
|
Nervous system disorders
Headache
|
2.9%
3/103 • Number of events 3 • Day 1 through Day 2.
|
0.00%
0/100 • Day 1 through Day 2.
|
0.98%
1/102 • Number of events 1 • Day 1 through Day 2.
|
0.94%
1/106 • Number of events 1 • Day 1 through Day 2.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/103 • Day 1 through Day 2.
|
2.0%
2/100 • Number of events 2 • Day 1 through Day 2.
|
0.98%
1/102 • Number of events 1 • Day 1 through Day 2.
|
0.00%
0/106 • Day 1 through Day 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/103 • Day 1 through Day 2.
|
0.00%
0/100 • Day 1 through Day 2.
|
0.98%
1/102 • Number of events 1 • Day 1 through Day 2.
|
1.9%
2/106 • Number of events 2 • Day 1 through Day 2.
|
|
Psychiatric disorders
Abnormal Dreams
|
0.00%
0/103 • Day 1 through Day 2.
|
1.0%
1/100 • Number of events 1 • Day 1 through Day 2.
|
2.0%
2/102 • Number of events 3 • Day 1 through Day 2.
|
0.94%
1/106 • Number of events 1 • Day 1 through Day 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/103 • Day 1 through Day 2.
|
2.0%
2/100 • Number of events 2 • Day 1 through Day 2.
|
0.00%
0/102 • Day 1 through Day 2.
|
0.94%
1/106 • Number of events 1 • Day 1 through Day 2.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place