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A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01748695
First Posted: December 12, 2012
Last Update Posted: April 11, 2017
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.
Collaborator:
Vernalis (R&D) Ltd
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital
Results First Submitted: December 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Neuropathic Pain Due to Spinal Cord Injury
Interventions: Drug: V158866
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Included a 14-day period to exclude non-compliers, extremes of pain ratings, and those with high variability

Reporting Groups
  Description
Placebo Followed by V158866 Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
V158866 Followed by Placebo V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks

Participant Flow for 2 periods

Period 1:   First Intervention (4 Weeks)
    Placebo Followed by V158866   V158866 Followed by Placebo
STARTED   14   11 
COMPLETED   14   11 
NOT COMPLETED   0   0 

Period 2:   Second Intervention (4 Weeks)
    Placebo Followed by V158866   V158866 Followed by Placebo
STARTED   14   11 
COMPLETED   14   11 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
V158866 and Placebo Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa

Baseline Measures
   V158866 and Placebo 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      25 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      7  28.0% 
Male      18  72.0% 


  Outcome Measures
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1.  Primary:   Mean Pain Intensity (NRS)   [ Time Frame: 4 Weeks ]

2.  Primary:   Safety and Tolerability of V158866 Compared to Placebo   [ Time Frame: 4 weeks ]


  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
No text entered.


  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: Dr. Christine N. Sang, Director of Translational Pain Research
Organization: Brigham and Women's Hospital
phone: 617-525-7246
e-mail: csang@partners.org



Responsible Party: Christine N. Sang, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01748695     History of Changes
Other Study ID Numbers: V158866-2Pa-01
First Submitted: December 11, 2012
First Posted: December 12, 2012
Results First Submitted: December 21, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017