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

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ClinicalTrials.gov Identifier: NCT01748695
Recruitment Status : Completed
First Posted : December 12, 2012
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Vernalis (R&D) Ltd
Information provided by (Responsible Party):
Christine N. Sang, MD, MPH, Brigham and Women's Hospital

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
Enrollment 25
Recruitment Details  
Pre-assignment Details Included a 14-day period to exclude non-compliers, extremes of pain ratings, and those with high variability
Arm/Group Title Placebo Followed by V158866 V158866 Followed by Placebo
Hide Arm/Group Description Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks
Period Title: First Intervention (4 Weeks)
Started 14 11
Completed 14 11
Not Completed 0 0
Period Title: Second Intervention (4 Weeks)
Started 14 11
Completed 14 11
Not Completed 0 0
Arm/Group Title V158866 and Placebo
Hide Arm/Group Description Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
7
  28.0%
Male
18
  72.0%
1.Primary Outcome
Title Mean Pain Intensity (NRS)
Hide Description Numerical Rating Scale, measuring the intensity of pain from 0 to 10, with 0 being no pain and 10 being worst pain imaginable. The comparison of the overall pain intensity, calculated as the mean of the last 7 days on treatment, for each treatment period (V158866 compared to placebo).
Time Frame 4 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo V158866
Hide Arm/Group Description:
Placebo once per day for 4 weeks
V158866 450mg once per day for 4 weeks
Overall Number of Participants Analyzed 25 25
Mean (Standard Error)
Unit of Measure: units on a scale
5.93  (0.148) 5.89  (0.148)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, V158866
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.834
Comments Based on a linear mixed measures model with treatment and period included as fixed effects, subject included as a random effect and between- and within- subject baseline covariates included.
Method Regression, Linear
Comments [Not Specified]
2.Primary Outcome
Title Safety and Tolerability of V158866 Compared to Placebo
Hide Description Safety and tolerability were measured by occurrence of treatment-emergent adverse events; data represents the number of subjects who experienced treatment-emergent adverse events during each treatment period.
Time Frame 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo V158866
Hide Arm/Group Description:
Placebo once per day for 4 weeks
V158866 450mg once per day for 4 weeks
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
7 12
Time Frame From start of study participation until all adverse events had resolved following study participation, an average of 4 months
Adverse Event Reporting Description All events that were possibly, probably, or definitely related to study medication
 
Arm/Group Title Placebo V158866
Hide Arm/Group Description Placebo once per day for 4 weeks V158866 450mg once per day for 4 Weeks
All-Cause Mortality
Placebo V158866
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo V158866
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo V158866
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/25 (28.00%)      12/25 (48.00%)    
Nervous system disorders     
Difficulty Concentrating   0/25 (0.00%)  0 3/25 (12.00%)  3
Fatigue (Sleepiness)   0/25 (0.00%)  0 4/25 (16.00%)  4
Headache   6/25 (24.00%)  6 2/25 (8.00%)  2
Drowsiness   2/25 (8.00%)  2 7/25 (28.00%)  8
Indicates events were collected by systematic assessment
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
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