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

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ClinicalTrials.gov Identifier: NCT00291187
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Insomnia
Interventions Drug: 20 mg VEC-162
Drug: 50 mg VEC-162
Drug: 100 mg VEC-162
Drug: Placebo
Enrollment 411
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.

Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Hide Arm/Group Description taken orally 30 minutes prior to bedtime 20 mg taken orally 30 minutes prior to bedtime 50 mg taken orally 30 minutes prior to bedtime 100 mg taken orally 30 minutes prior to bedtime
Period Title: Overall Study
Started 103 100 103 106
Completed 103 100 102 106
Not Completed 0 0 1 0
Reason Not Completed
Protocol Violation- No Drug Administered             0             0             1             0
Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg Total
Hide Arm/Group Description Taken orally 30 minutes prior to bedtime. 20 mg taken orally 30 minutes prior to bedtime. 50 mg taken orally 30 minutes prior to bedtime. 100 mg taken orally 30 minutes prior to bedtime. Total of all reporting groups
Overall Number of Baseline Participants 103 100 102 106 411
Hide Baseline Analysis Population Description
Modified Intent-to-Treat. A total of 411 subjects received treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 100 participants 102 participants 106 participants 411 participants
30.9  (7.28) 30.8  (8.41) 31.0  (8.51) 31.2  (8.19) 31.0  (8.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 100 participants 102 participants 106 participants 411 participants
Female
68
  66.0%
62
  62.0%
58
  56.9%
73
  68.9%
261
  63.5%
Male
35
  34.0%
38
  38.0%
44
  43.1%
33
  31.1%
150
  36.5%
1.Primary Outcome
Title Average Improvement of Latency to Persistent Sleep (LPS)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Hide Arm/Group Description:
Taken orally 30 minutes prior to bedtime.
20 mg taken orally 30 minutes prior to bedtime.
50 mg taken orally 30 minutes prior to bedtime.
100 mg taken orally 30 minutes prior to bedtime.
Overall Number of Participants Analyzed 103 100 102 106
Mean (Standard Error)
Unit of Measure: minutes
45.8  (4.28) 24.3  (4.35) 19.6  (4.31) 23.1  (4.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -21.5
Confidence Interval (2-Sided) 95%
-33.1 to -9.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -26.3
Confidence Interval (2-Sided) 95%
-37.8 to -14.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -22.8
Confidence Interval (2-Sided) 95%
-34.2 to -11.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Average Improvement of Wake After Sleep Onset (WASO)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Hide Arm/Group Description:
Taken orally 30 minutes prior to bedtime.
20 mg taken orally 30 minutes prior to bedtime
50 mg taken orally 30 minutes prior to bedtime
100 mg taken orally 30 minutes prior to bedtime
Overall Number of Participants Analyzed 103 100 102 106
Mean (Standard Error)
Unit of Measure: minutes
139.3  (7.33) 115.1  (7.46) 105.6  (7.39) 121.9  (7.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -24.2
Confidence Interval (2-Sided) 95%
-44.1 to -4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.7
Confidence Interval (2-Sided) 95%
-53.6 to -13.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -17.4
Confidence Interval (2-Sided) 95%
-37.0 to 2.1
Estimation Comments [Not Specified]
3.Post-Hoc Outcome
Title Average Improvement in Total Sleep Time (TST)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Hide Arm/Group Description:
Taken orally 30 minutes prior to bedtime.
20 mg taken orally 30 minutes prior to bedtime.
50 mg taken orally 30 minutes prior to bedtime.
100 mg taken orally 30 minutes prior to bedtime.
Overall Number of Participants Analyzed 103 100 102 106
Mean (Standard Error)
Unit of Measure: Minutes
317.6  (7.65) 351.4  (7.78) 365.5  (7.71) 347.2  (7.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 33.7
Confidence Interval (2-Sided) 95%
13.0 to 54.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 47.9
Confidence Interval (2-Sided) 95%
27.2 to 68.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 29.6
Confidence Interval (2-Sided) 95%
9.1 to 50.0
Estimation Comments [Not Specified]
4.Post-Hoc Outcome
Title Average Improvement in Latency to Non-awake (LNA)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Hide Arm/Group Description:
Taken orally 30 minutes prior to bedtime
20 mg taken orally 30 minutes prior to bedtime.
50 mg taken orally 30 minutes prior to bedtime.
100 mg taken orally 30 minutes prior to bedtime.
Overall Number of Participants Analyzed 103 100 102 106
Mean (Standard Error)
Unit of Measure: Minutes
22.3  (2.88) 11.2  (2.93) 8.0  (2.90) 10.0  (2.84)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 20 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -11.1
Confidence Interval (2-Sided) 95%
-18.9 to -3.3
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.3
Confidence Interval (2-Sided) 95%
-22.1 to -6.5
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, VEC-162 100 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -12.3
Confidence Interval (2-Sided) 95%
-20.0 to -4.6
Estimation Comments [Not Specified]
Time Frame Day 1 through Day 2.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Hide Arm/Group Description Taken orally 30 minutes prior to bedtime. 20 mg taken orally 30 minutes prior to bedtime. 50 mg taken orally 30 minutes prior to bedtime. 100 mg taken orally 30 minutes prior to bedtime.
All-Cause Mortality
Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/103 (0.00%)      0/100 (0.00%)      0/102 (0.00%)      0/106 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo VEC-162 20 mg VEC-162 50 mg VEC-162 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/103 (4.85%)      7/100 (7.00%)      5/102 (4.90%)      6/106 (5.66%)    
Gastrointestinal disorders         
Nausea  1  3/103 (2.91%)  3 3/100 (3.00%)  3 3/102 (2.94%)  3 3/106 (2.83%)  3
Dry Mouth  1  0/103 (0.00%)  0 2/100 (2.00%)  2 1/102 (0.98%)  1 0/106 (0.00%)  0
Dyspepsia  1  0/103 (0.00%)  0 0/100 (0.00%)  0 1/102 (0.98%)  1 2/106 (1.89%)  2
Nervous system disorders         
Headache  1  3/103 (2.91%)  3 0/100 (0.00%)  0 1/102 (0.98%)  1 1/106 (0.94%)  1
Psychiatric disorders         
Abnormal Dreams  1  0/103 (0.00%)  0 1/100 (1.00%)  1 2/102 (1.96%)  3 1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders         
Dry Throat  1  0/103 (0.00%)  0 2/100 (2.00%)  2 0/102 (0.00%)  0 1/106 (0.94%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marlene Dressman, PhD.
Organization: Vanda Pharmaceuticals Inc.
Phone: 202-734-3462
Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00291187     History of Changes
Other Study ID Numbers: VP-VEC-162-3101
First Submitted: February 3, 2006
First Posted: February 13, 2006
Results First Submitted: February 28, 2014
Results First Posted: October 15, 2014
Last Update Posted: October 15, 2014