Trial Outcomes & Findings for Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (NCT NCT05639946)

NCT ID: NCT05639946

Last Updated: 2026-03-18

Results Overview

use Next-Generation sequencing to assess miR-485 levels

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

44 participants

Primary outcome timeframe

baseline

Results posted on

2026-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Group Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
Overall Study STARTED	22	22
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Group Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
Overall Study Physician Decision	0	2
Overall Study Protocol Violation	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=22 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=21 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug	Total n=43 Participants Total of all reporting groups
Age, Continuous	51.27 years STANDARD_DEVIATION 15.30 • n=110 Participants	52.71 years STANDARD_DEVIATION 12.34 • n=114 Participants	51.98 years STANDARD_DEVIATION 13.79 • n=224 Participants
Sex: Female, Male Female	5 Participants n=110 Participants	4 Participants n=114 Participants	9 Participants n=224 Participants
Sex: Female, Male Male	17 Participants n=110 Participants	17 Participants n=114 Participants	34 Participants n=224 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=110 Participants	0 Participants n=114 Participants	0 Participants n=224 Participants
Race (NIH/OMB) Asian	0 Participants n=110 Participants	0 Participants n=114 Participants	0 Participants n=224 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=110 Participants	0 Participants n=114 Participants	0 Participants n=224 Participants
Race (NIH/OMB) Black or African American	1 Participants n=110 Participants	0 Participants n=114 Participants	1 Participants n=224 Participants
Race (NIH/OMB) White	21 Participants n=110 Participants	19 Participants n=114 Participants	40 Participants n=224 Participants
Race (NIH/OMB) More than one race	0 Participants n=110 Participants	2 Participants n=114 Participants	2 Participants n=224 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=110 Participants	0 Participants n=114 Participants	0 Participants n=224 Participants

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Average Worst Neuropathic Pain Intensity assesses the average worst neuropathic pain intensity in the last week using a 0-10 numerical rating scale where higher scores represent greater pain intensity. Change in pain intensity will be evaluated by comparing baseline intensity with 7-week post intervention intensity.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity	-0.5 points Standard Deviation 2.0	-0.5 points Standard Deviation 1.5

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain assesses the average of the three worst neuropathic pain intensities in the last week using a 0-10 numerical rating scale where higher scores represent greater pain intensity. Change in average pain intensity will be evaluated by comparing baseline average intensity with 7-week post intervention average intensity.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain	-0.5 points Standard Deviation 1.9	-0.6 points Standard Deviation 1.7

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged over all Pain Sites assesses the average pain intensities over all pain sites in the last week using a 0-10 numerical rating scale where higher scores represent greater pain intensity. Change in average pain intensity for all pain sites will be evaluated by comparing baseline average intensity with 7-week post intervention average intensity over all pain sites.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged Over All Pain Sites	-0.9 points Standard Deviation 2.3	-0.9 points Standard Deviation 3.5

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference assesses interference of the worst neuropathic pain with daily activities in the last week using a 0-10 numerical rating scale where higher scores represent greater pain interference. Change in pain interference on daily activities will be evaluated by comparing baseline interference with 7-week post intervention interference.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference	-0.8 points Standard Deviation 2.8	-0.4 points Standard Deviation 3.5

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference with Mood assesses the interference of the worst neuropathic pain on mood in the last week using a 0-10 numerical rating scale where higher scores represent greater pain interference. Change in pain interference on mood will be evaluated by comparing baseline interference with 7-week post intervention interference.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood	-0.1 points Standard Deviation 1.7	-0.8 points Standard Deviation 3.0

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference with Sleep assesses the interference of the worst neuropathic pain on sleep in the last week using a 0-10 numerical rating scale where higher scores represent greater pain interference. Change in pain interference on sleep will be evaluated by comparing baseline interference with 7-week post intervention interference.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Sleep	-1.0 points Standard Deviation 1.7	-1.2 points Standard Deviation 2.7

PRIMARY outcome

Timeframe: 7 Weeks Post Intervention

The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Pain Interference assesses the average overall interference of the worst neuropathic pain (average interference of daily activities, mood, and sleep) in the last week using a 0-10 numerical rating scale where higher scores represent greater pain interference. Change in overall interference will be evaluated by comparing baseline overall interference with 7-week post intervention overall interference.

Outcome measures

Outcome measures
Measure	Experimental Group n=21 Participants Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 Participants Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Pain Interference	-0.7 points Standard Deviation 1.7	-0.8 points Standard Deviation 2.7

PRIMARY outcome

Timeframe: 7 weeks

Population: The clinical trial allowed for in-person or fully remote participation; and when participating fully remote, in-person data collection were allowed not to be collected (e.g. MRI scan, blood banking for microRNA). Therefore, the clinical trial did not have sufficient paired data collected to analyze MRI or microRNA outcomes. For the MRI data, no change can be determined with only 1 timepoint. Data do not exist for a change analysis.

assess changes in cortical activity of related pain perception regions and networks in the brain in response to brivaracetam treatment compared to placebo using rsfMRI and pain- related task-based fMRI. Although MRI data were acquired, the predefined functional connectivity analysis pipeline was not completed; therefore, no operculum connectivity outcomes were generated or analyzed for this study.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: baseline

Population: This outcome measure was prespecified at study registration, but the laboratory analysis required to generate miRNA data was not conducted. As a result, no data exist to summarize or report for this outcome. Samples failed pre-analytical quality control required for miRNA extraction and PCR quantification; therefore, miRNA assays were not performed and no miRNA data were generated

use Next-Generation sequencing to assess miR-485 levels

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 7 weeks

Population: This outcome measure was prespecified at study registration, but the laboratory analysis required to generate miRNA data was not conducted. As a result, no data exist to summarize or report for this outcome. Samples failed pre-analytical quality control required for miRNA extraction and PCR quantification; therefore, miRNA assays were not performed and no miRNA data were generated

use Next-Generation sequencing to assess miR-485 levels

Outcome measures

Outcome data not reported

Adverse Events

Experimental Group

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Experimental Group n=21 participants at risk Participants with severe neuropathic pain will receive brivaracetam treatment brivaracetam: Drug dosage will be individually titrated for each participant with a goal of 100mg BID according to the following dose escalation protocol that we use clinically: 50mg BID for 1 week followed by 100mg BID for 28 days as tolerated. Participants will be allowed to reduce the dose of brivaracetam if they experience unacceptable side effects defined as increased somnolence according to routine clinical practice with other drugs in this class used for pain. Drug discontinuation at study completion will be done according to the following protocol we use clinically that will be initiated for 2 weeks: reduction to 50mg BID for 1 week followed by 50mg daily for 1 week.	Control Group n=19 participants at risk Participants with severe neuropathic pain will receive placebo drug Placebo: Participants will receive placebo drug
Gastrointestinal disorders Bowel/ GI	9.5% 2/21 • Number of events 2 • 7 weeks post-intervention	10.5% 2/19 • Number of events 7 • 7 weeks post-intervention
Product Issues Capsule Size Intolerance	4.8% 1/21 • Number of events 1 • 7 weeks post-intervention	0.00% 0/19 • 7 weeks post-intervention
General disorders Drowsiness/ Fatigue	42.9% 9/21 • Number of events 14 • 7 weeks post-intervention	21.1% 4/19 • Number of events 6 • 7 weeks post-intervention
Nervous system disorders Headache	0.00% 0/21 • 7 weeks post-intervention	5.3% 1/19 • Number of events 1 • 7 weeks post-intervention
Nervous system disorders Pain	4.8% 1/21 • Number of events 1 • 7 weeks post-intervention	5.3% 1/19 • Number of events 1 • 7 weeks post-intervention
Psychiatric disorders Mood	4.8% 1/21 • Number of events 2 • 7 weeks post-intervention	0.00% 0/19 • 7 weeks post-intervention
Skin and subcutaneous tissue disorders Rash	0.00% 0/21 • 7 weeks post-intervention	5.3% 1/19 • Number of events 2 • 7 weeks post-intervention
Musculoskeletal and connective tissue disorders Spasticity	4.8% 1/21 • Number of events 1 • 7 weeks post-intervention	0.00% 0/19 • 7 weeks post-intervention

Additional Information

Angela Philippus

University of Minnesota

Phone: (612) 626-5399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place