Trial Outcomes & Findings for A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury (NCT NCT01748695)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

4 Weeks

Results posted on

2017-04-11

Participant Flow

Included a 14-day period to exclude non-compliers, extremes of pain ratings, and those with high variability

Participant milestones

Participant milestones
Measure	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
First Intervention (4 Weeks) STARTED	14	11
First Intervention (4 Weeks) COMPLETED	14	11
First Intervention (4 Weeks) NOT COMPLETED	0	0
Second Intervention (4 Weeks) STARTED	14	11
Second Intervention (4 Weeks) COMPLETED	14	11
Second Intervention (4 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V158866 and Placebo n=25 Participants Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 Weeks

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).

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo once per day for 4 weeks	V158866 n=25 Participants V158866 450mg once per day for 4 weeks
Mean Pain Intensity (NRS)	5.93 units on a scale Standard Error 0.148	5.89 units on a scale Standard Error 0.148

PRIMARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants Placebo once per day for 4 weeks	V158866 n=25 Participants V158866 450mg once per day for 4 weeks
Safety and Tolerability of V158866 Compared to Placebo	7 Participants	12 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

V158866

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=25 participants at risk Placebo once per day for 4 weeks	V158866 n=25 participants at risk V158866 450mg once per day for 4 Weeks
Nervous system disorders Difficulty Concentrating	0.00% 0/25 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication	12.0% 3/25 • Number of events 3 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication
Nervous system disorders Fatigue (Sleepiness)	0.00% 0/25 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication	16.0% 4/25 • Number of events 4 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication
Nervous system disorders Headache	24.0% 6/25 • Number of events 6 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication	8.0% 2/25 • Number of events 2 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication
Nervous system disorders Drowsiness	8.0% 2/25 • Number of events 2 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication	28.0% 7/25 • Number of events 8 • From start of study participation until all adverse events had resolved following study participation, an average of 4 months All events that were possibly, probably, or definitely related to study medication

Additional Information

Dr. Christine N. Sang, Director of Translational Pain Research

Brigham and Women's Hospital

Phone: 617-525-7246

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place