Trial · NCT04379011
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
NCT04379011, Phase 1, Phase 2, Completed, University of Minnesota; results first posted 2025-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury. Trials, record NCT04379011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04379011
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
- NCT number
- NCT04379011
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Spinal Cord Injuries
- Interventions
- Brivaracetam, Placebo
- First posted
- 2020-05-07
- Last updated
- 2025-10-14
- Results first posted
- 2025-04-27
- Limitations and caveats
- The protocol did not allow for assessment of pain scores prior to or after the intervention.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Brief Pain Inventory, Worst Pain | baseline | The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities. |
| Primary | Brief Pain Inventory, Worst Pain | 3 months | The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities. |
| Primary | Brief Pain Inventory, Least Pain | baseline | The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities. |
| Primary | Brief Pain Inventory, Least Pain | 3 months | The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities. |
| Primary | Brief Pain Inventory, Average Pain | baseline | The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities. |
| Primary | Brief Pain Inventory, Average Pain | 3 months | The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities. |
| Primary | Satisfaction With Life Scale (SWLS) | baseline | The satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life. |
| Primary | Satisfaction With Life Scale (SWLS) | 3 months | The satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Brief Pain Inventory, Worst Pain | baseline | score on scale | MEAN | |
| PRIMARY | Brief Pain Inventory, Worst Pain | 3 months | score on scale | MEAN | |
| PRIMARY | Brief Pain Inventory, Least Pain | baseline | score on scale | MEAN | |
| PRIMARY | Brief Pain Inventory, Least Pain | 3 months | score on scale | MEAN | |
| PRIMARY | Brief Pain Inventory, Average Pain | baseline | score on scale | MEAN | |
| PRIMARY | Brief Pain Inventory, Average Pain | 3 months | score on scale | MEAN | |
| PRIMARY | Satisfaction With Life Scale (SWLS) | baseline | score on a scale | MEAN | |
| PRIMARY | Satisfaction With Life Scale (SWLS) | 3 months | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Brief Pain Inventory, Worst Pain | Control Group | 8.9 | Standard Deviation 1 | score on scale | |
| Brief Pain Inventory, Worst Pain | Brivaracetam Group | 9.7 | Standard Deviation 0.8 | score on scale | |
| Brief Pain Inventory, Worst Pain | Control Group | 8.1 | Standard Deviation 1.6 | score on scale | |
| Brief Pain Inventory, Worst Pain | Brivaracetam Group | 7.8 | Standard Deviation 1.7 | score on scale | |
| Brief Pain Inventory, Least Pain | Control Group | 5.1 | Standard Deviation 3.3 | score on scale | |
| Brief Pain Inventory, Least Pain | Brivaracetam Group | 4.8 | Standard Deviation 3.2 | score on scale | |
| Brief Pain Inventory, Least Pain | Control Group | 5.6 | Standard Deviation 2.4 | score on scale | |
| Brief Pain Inventory, Least Pain | Brivaracetam Group | 4.7 | Standard Deviation 3.4 | score on scale | |
| Brief Pain Inventory, Average Pain | Control Group | 6.7 | Standard Deviation 1.8 | score on scale | |
| Brief Pain Inventory, Average Pain | Brivaracetam Group | 7.5 | Standard Deviation 1.6 | score on scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Group | 12 | |
| Overall Study | STARTED | Brivaracetam Group | 12 | |
| Overall Study | COMPLETED | Control Group | 9 | |
| Overall Study | COMPLETED | Brivaracetam Group | 11 | |
| Overall Study | NOT COMPLETED | Control Group | 3 | |
| Overall Study | NOT COMPLETED | Brivaracetam Group | 1 |
Source ClinicalTrials.gov
Adverse events12
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 | gastrointestinal symptoms | Gastrointestinal disorders | Control Group | 0 | 9 | 0 |
| other | gastrointestinal symptoms | Gastrointestinal disorders | Brivaracetam Group | 5 | 11 | 9 |
| other | neurological symptoms | Nervous system disorders | Control Group | 3 | 9 | 3 |
| other | neurological symptoms | Nervous system disorders | Brivaracetam Group | 5 | 11 | 6 |
| other | fatigue | General disorders | Control Group | 2 | 9 | 2 |
| other | fatigue | General disorders | Brivaracetam Group | 5 | 11 | 5 |
| other | psychological symptoms | General disorders | Control Group | 2 | 9 | 2 |
| other | psychological symptoms | General disorders | Brivaracetam Group | 3 | 11 | 3 |
| other | vasomotor symptoms | General disorders | Control Group | 1 | 9 | 1 |
| other | vasomotor symptoms | General disorders | Brivaracetam Group | 0 | 11 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Group | 0 | 9 |
| Total, all-cause mortality | Brivaracetam Group | 0 | 11 |
| Total, other adverse events | Control Group | 8 | 9 |
| Total, other adverse events | Brivaracetam Group | 11 | 11 |
| Total, serious adverse events | Control Group | 0 | 9 |
| Total, serious adverse events | Brivaracetam Group | 1 | 11 |
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 |
|---|---|
| Brivaracetam Group vs Control Group: deaths from any cause | Trial comparisons |
| Brivaracetam 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/NCT04379011
GET https://conductscience.org/api/trials/v1/NCT04379011/registered