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Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to all pharmacological intervention. Preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in SCI. This randomized, placebo-controlled pilot clinical trial will assess feasibility of a 3-month treatment course with brivarecetum.
The investigations will assess changes in pain intensity and periaqueductal gray hyperactivity. Baseline periaqueductal gray hyperactivity and microRNA levels will be measured as potential biomarkers of response to treatment. These preliminary findings will be used to design larger clinical trials to establish efficacy of brivarecetum to treat neuropathic pain in SCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brivaracetam Group | Experimental | Participants in this arm will receive the investigational drug, Brivaracetam. |
|
| Control Group | Placebo Comparator | Participants in this arm will receive a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brivaracetam | Drug | Escalating brivaracetam dose to 150 mg twice daily for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory, Worst Pain | 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. | baseline |
| Brief Pain Inventory, Worst Pain | 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. | 3 months |
| Brief Pain Inventory, Least Pain | 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. | baseline |
| Brief Pain Inventory, Least Pain | 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Morse, DO | University of Minnesota | Study Director |
| Scott Falci, MD | Swedish Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swedish Hospital | Englewood | Colorado | 80113 | United States | ||
| University of Minnesota School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants in this arm will receive a placebo. Placebo: Placebo twice daily for 3 months |
| FG001 | Brivaracetam Group | Participants in this arm will receive the investigational drug, Brivaracetam. Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Participants in this arm will receive a placebo. Placebo: Placebo twice daily for 3 months |
| BG001 | Brivaracetam Group | Participants in this arm will receive the investigational drug, Brivaracetam. Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Brief Pain Inventory, Worst Pain | 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. | Posted | Mean | Standard Deviation | score on scale | baseline |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants in this arm will receive a placebo. Placebo: Placebo twice daily for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization due to nausea and vomiting | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal symptoms | Gastrointestinal disorders | Non-systematic Assessment |
The protocol did not allow for assessment of pain scores prior to or after the intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ricardo Battaglino | University of Minnesota | 612-625-2661 | rbattagal@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 18, 2024 | Mar 21, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2022 | Mar 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| C482793 | brivaracetam |
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| Placebo | Other | Placebo twice daily for 3 months |
|
| Brief Pain Inventory, Average Pain |
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. |
| baseline |
| Brief Pain Inventory, Average Pain | 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. | 3 months |
| Satisfaction With Life Scale (SWLS) | 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. | baseline |
| Satisfaction With Life Scale (SWLS) | 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. | 3 months |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Brief Pain Inventory, Worst Pain | 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. | Posted | Mean | Standard Deviation | score on scale | 3 months |
|
|
|
| Primary | Brief Pain Inventory, Least Pain | 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. | Posted | Mean | Standard Deviation | score on scale | baseline |
|
|
|
| Primary | Brief Pain Inventory, Least Pain | 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. | Posted | Mean | Standard Deviation | score on scale | 3 months |
|
|
|
| Primary | Brief Pain Inventory, Average Pain | 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. | Posted | Mean | Standard Deviation | score on scale | baseline |
|
|
|
| Primary | Brief Pain Inventory, Average Pain | 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. | Posted | Mean | Standard Deviation | score on scale | 3 months |
|
|
|
| Primary | Satisfaction With Life Scale (SWLS) | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline |
|
|
|
| Primary | Satisfaction With Life Scale (SWLS) | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 8 |
| 9 |
| EG001 | Brivaracetam Group | Participants in this arm will receive the investigational drug, Brivaracetam. Brivaracetam: Escalating brivaracetam dose to 150 mg twice daily for 3 months | 0 | 11 | 1 | 11 | 11 | 11 |
| neurological symptoms | Nervous system disorders | Non-systematic Assessment |
|
| fatigue | General disorders | Non-systematic Assessment |
|
| psychological symptoms | General disorders | Non-systematic Assessment |
|
| vasomotor symptoms | General disorders | Non-systematic Assessment |
|
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| D014947 | Wounds and Injuries |