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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291187
Recruitment Status : Completed
First Posted : February 13, 2006
Results First Posted : October 15, 2014
Last Update Posted : October 15, 2014
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

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.

Reporting Groups
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

Participant Flow:   Overall Study
    Placebo   VEC-162 20 mg   VEC-162 50 mg   VEC-162 100 mg
STARTED   103   100   103   106 
COMPLETED   103   100   102   106 
NOT COMPLETED   0   0   1   0 
Protocol Violation- No Drug Administered                0                0                1                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent-to-Treat. A total of 411 subjects received treatment.

Reporting Groups
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.
Total Total of all reporting groups

Baseline Measures
   Placebo   VEC-162 20 mg   VEC-162 50 mg   VEC-162 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   100   102   106   411 
[Units: Years]
Mean (Standard Deviation)
 30.9  (7.28)   30.8  (8.41)   31.0  (8.51)   31.2  (8.19)   31.0  (8.08) 
[Units: Participants]
Female   68   62   58   73   261 
Male   35   38   44   33   150 

  Outcome Measures

1.  Primary:   Average Improvement of Latency to Persistent Sleep (LPS)   [ Time Frame: Night 1 ]

2.  Secondary:   Average Improvement of Wake After Sleep Onset (WASO)   [ Time Frame: Night 1 ]

3.  Post-Hoc:   Average Improvement in Total Sleep Time (TST)   [ Time Frame: Night 1 ]

4.  Post-Hoc:   Average Improvement in Latency to Non-awake (LNA)   [ Time Frame: Night 1 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Vanda Pharmaceuticals 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