Trial · NCT05639946
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
NCT05639946, Phase 3, Completed, University of Minnesota; results first posted 2026-03-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Trials, record NCT05639946. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05639946
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- NCT number
- NCT05639946
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Interventions
- brivaracetam, Placebo
- First posted
- 2022-12-07
- Last updated
- 2026-03-18
- Results first posted
- 2026-03-18
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity | 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. |
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain | 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. |
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged Over All Pain Sites | 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. |
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference | 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. |
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood | 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. |
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Sleep | 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. |
| Primary | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Pain Interference | 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. |
| Primary | Change in Operculum Brain Connectivity | 7 weeks | 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. |
| Primary | microRNA-485 Levels | baseline | use Next-Generation sequencing to assess miR-485 levels |
| Primary | microRNA-485 Levels | 7 weeks | use Next-Generation sequencing to assess miR-485 levels |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged Over All Pain Sites | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Sleep | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Pain Interference | 7 Weeks Post Intervention | points | MEAN | |
| PRIMARY | Change in Operculum Brain Connectivity | 7 weeks | 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. | ||
| PRIMARY | microRNA-485 Levels | baseline | 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 | ||
| PRIMARY | microRNA-485 Levels | 7 weeks | 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 |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity | Experimental Group | -0.5 | Standard Deviation 2.0 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity | Control Group | -0.5 | Standard Deviation 1.5 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain | Experimental Group | -0.5 | Standard Deviation 1.9 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain | Control Group | -0.6 | Standard Deviation 1.7 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged Over All Pain Sites | Experimental Group | -0.9 | Standard Deviation 2.3 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged Over All Pain Sites | Control Group | -0.9 | Standard Deviation 3.5 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference | Experimental Group | -0.8 | Standard Deviation 2.8 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference | Control Group | -0.4 | Standard Deviation 3.5 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood | Experimental Group | -0.1 | Standard Deviation 1.7 | points | |
| The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood | Control Group | -0.8 | Standard Deviation 3.0 | points |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Group | 22 | |
| Overall Study | STARTED | Control Group | 22 | |
| Overall Study | COMPLETED | Experimental Group | 21 | |
| Overall Study | COMPLETED | Control Group | 19 | |
| Overall Study | NOT COMPLETED | Experimental Group | 1 | |
| Overall Study | NOT COMPLETED | Control Group | 3 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bowel/ GI | Gastrointestinal disorders | Experimental Group | 2 | 21 | 2 |
| other | Bowel/ GI | Gastrointestinal disorders | Control Group | 2 | 19 | 7 |
| other | Capsule Size Intolerance | Product Issues | Experimental Group | 1 | 21 | 1 |
| other | Capsule Size Intolerance | Product Issues | Control Group | 0 | 19 | 0 |
| other | Drowsiness/ Fatigue | General disorders | Experimental Group | 9 | 21 | 14 |
| other | Drowsiness/ Fatigue | General disorders | Control Group | 4 | 19 | 6 |
| other | Headache | Nervous system disorders | Experimental Group | 0 | 21 | 0 |
| other | Headache | Nervous system disorders | Control Group | 1 | 19 | 1 |
| other | Pain | Nervous system disorders | Experimental Group | 1 | 21 | 1 |
| other | Pain | Nervous system disorders | Control Group | 1 | 19 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental Group | 0 | 21 |
| Total, all-cause mortality | Control Group | 0 | 19 |
| Total, other adverse events | Experimental Group | 15 | 21 |
| Total, other adverse events | Control Group | 9 | 19 |
| Total, serious adverse events | Experimental Group | 0 | 21 |
| Total, serious adverse events | Control Group | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental Group vs Control Group: deaths from any cause | Trial comparisons |
| Experimental Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05639946
GET https://conductscience.org/api/trials/v1/NCT05639946/registered