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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00291187
First received: February 3, 2006
Last updated: October 8, 2014
Last verified: October 2014
Results First Received: February 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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
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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
  Description
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
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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
  Description
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  
Number of Participants  
[units: participants]
  103     100     102     106     411  
Age  
[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  
Gender  
[units: participants]
         
Female     68     62     58     73     261  
Male     35     38     44     33     150  



  Outcome Measures
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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
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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
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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
e-mail: marlene.dressman@vandapharma.com


No publications provided by Vanda Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00291187     History of Changes
Other Study ID Numbers: VP-VEC-162-3101
Study First Received: February 3, 2006
Results First Received: February 28, 2014
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration