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

• 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: Brigham and Women's Hospital
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		V158866 and Placebo
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
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%

Outcome Measures

1. Primary Outcome

Title	Mean Pain Intensity (NRS)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	V158866
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)

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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	V158866
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

Adverse Events

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
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	--/--		--/--
Serious Adverse Events
	Placebo		V158866
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0.00%)		0/25 (0.00%)
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

Limitations and Caveats

[Not Specified]

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

• Responsible Party: Christine N. Sang, MD, MPH, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT01748695
• 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