Spinal Cord InjuriesPhase 3NCT05639946
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
A Phase 3 study testing brivaracetam in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Minnesota at 1 site in United States.
Trial summary
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Neuropathic Pain
- What is being tested?
- brivaracetam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 16 Oct 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Injured for \> 3 months
- Completed inpatient rehabilitation and living in the community
- Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3-10) for three months or more
- For people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly).
Who cannot join
- Progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
- Active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin.
- Brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent
- Pregnancy or lactation
- Epilepsy or active treatment for seizure disorder
- Past or current suicidality
Show all 16Show fewer
- Active treatment for psychiatric disease
- Drug addiction
- Moderate or heavy alcohol intake (up to four alcoholic drinks for men and three for women in any single day, and a maximum of 14 drinks for men and 7 drinks for women per week)
- Hepatic cirrhosis, Child-Pugh grades A, B, and C
- Impaired renal function (GFR\<60ml/minute)
- Contraindications to brivaracetam or pyrrolidine derivatives including allergy
- Active clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
- History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of brivaracetam
- Use of any investigational drug 30 days prior to enrollment in this study
- Enrollment in another clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum (partsOP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). Circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. The study aims to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain.
Read the detailed description
Purpose:
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Our preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on our data and other reports in the literature, we hypothesize that SCI-related neuropathic pain occurs largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. We further hypothesize that, compared to placebo, brivaracetam treatment reduces severe below-level SCI neuropathic pain and increases parietal operculum (parts OP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). We also hypothesize that circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. To test these hypotheses, we will conduct a randomized, double-blind, placebo-controlled clinical trial to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain. We therefore propose the following:
Specific Aims:
Specific Aim 1: Determine whether a 7-week course of daily brivaracetam reduces below-level neuropathic pain in SCI. The objective of this aim is to assess efficacy of a 7-week course of brivaracetam to reduce neuropathic pain in men and women with SCI. We will assess change in pain intensity and related outcomes, including mood, satisfaction with life, and community integration. We will monitor drug adverse events and tolerability.
Specific Aim 2: Determine whether a 7-week course of daily brivaracetam increases parietal operculum brain connectivity. The objective of this exploratory aim is to assess the effect of a 7-week course of brivaracetam treatment on parietal operculum activation and connectivity in SCI. We will 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. To achieve this aim, we will test the working hypothesis that brivaracetam increases parietal operculum activation and connectivity compared to placebo, using rsfMRI, task-based fMRI, and a validated image processing protocol. We will also examine changes in network connectivity and brain activity in the insula, because of its concurrent reported importance for neuropathic pain in SCI. We will assess the association between functional connectivity of the parietal operculum and the insula and change in pain intensity in response to brivaracetam treatment.
Specific Aim 3: Determine whether baseline microRNA-485 levels are associated with response to brivaracetam treatment. The objective of this exploratory aim is to assess microRNA expression as a potential predictive biomarker of response to brivaracetam treatment. To achieve this, we will test the working hypothesis that baseline circulating miR-485 levels predict change in pain intensity in response to brivaracetam treatment. To test this, we will use Next-Generation sequencing. We will assess miR-485 levels at baseline and after a three-month treatment course.
Significance of Research Question/Purpose:
There is currently no effective pharmacological treatment for severe neuropathic pain in SCI. Identification of an oral medication that is effective, safe, and well tolerated would represent a major improvement in the clinical approach to neuropathic pain in SCI. Additionally, there are no validated predictive biomarkers of response to pharmacological therapy in neuropathic pain after SCI. This work is innovative as it seeks to develop a new, mechanism-based pharmacological intervention for neuropathic pain in SCI. Additionally, this project seeks to identify novel biomarkers of neuropathic pain and response to therapy. Development of a reliable, easy to measure biomarker that distinguishes responders from non-responders would dramatically improve clinical care for this condition. Successful completion of this work will rapidly lead to larger clinical trials testing drug efficacy and validating novel predictive biomarkers of treatment response.
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Being tested
- brivaracetam, Placebo
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brivaracetamDrug
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.
PlaceboDrug
Participants will receive placebo drug
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Drug: brivaracetam |
| Control group | Placebo comparator | Participants with severe neuropathic pain will receive placebo drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity
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.
Measured: 7 Weeks Post Intervention
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain
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.
Measured: 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
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.
Measured: 7 Weeks Post Intervention
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference
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.
Measured: 7 Weeks Post Intervention
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood
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.
Measured: 7 Weeks Post Intervention
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Sleep
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.
Measured: 7 Weeks Post Intervention
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Pain Interference
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.
Measured: 7 Weeks Post Intervention
Change in Operculum Brain Connectivity
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.
Measured: 7 weeks
microRNA-485 Levels
use Next-Generation sequencing to assess miR-485 levels
Measured: baseline
microRNA-485 Levels
use Next-Generation sequencing to assess miR-485 levels
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start1 Jan 2023
- Primary completion7 Oct 2024
- Study completion16 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Battaglino, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639946
- Sponsor's protocol ID
- PMR-2022-30886
- Status last verified
- Feb 2026
- First submitted
- 23 Nov 2022
- Last updated
- 18 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05639946
- Acronym / sponsor ID
- PMR-2022-30886
- Conditions
- Spinal Cord Injuries, Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 7 Dec 2022 (actual)
- Results
- Posted 18 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on this and other reports in the literature, SCI-related neuropathic pain is hypothesized to occur largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum (partsOP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). Circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. The study aims to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain.
Detailed description
Purpose:
Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to pharmacological intervention. Our preliminary data suggest brivaracetam is a mechanism-based pharmacological intervention for neuropathic pain in SCI. Based on our data and other reports in the literature, we hypothesize that SCI-related neuropathic pain occurs largely because of upregulation of synaptic vesicle protein 2A (SV2A) within the substantia gelatinosa of the injured spinal cord. We further hypothesize that, compared to placebo, brivaracetam treatment reduces severe below-level SCI neuropathic pain and increases parietal operculum (parts OP1/OP4) connectivity strength measured by resting-state functional Magnetic Resonance Imaging (rsfMRI). We also hypothesize that circulating miRNA-485 levels may be associated with change in pain intensity due to brivaracetam treatment. To test these hypotheses, we will conduct a randomized, double-blind, placebo-controlled clinical trial to determine the efficacy of brivaracetam treatment for SCI-related neuropathic pain. We therefore propose the following:
Specific Aims:
Specific Aim 1: Determine whether a 7-week course of daily brivaracetam reduces below-level neuropathic pain in SCI. The objective of this aim is to assess efficacy of a 7-week course of brivaracetam to reduce neuropathic pain in men and women with SCI. We will assess change in pain intensity and related outcomes, including mood, satisfaction with life, and community integration. We will monitor drug adverse events and tolerability.
Specific Aim 2: Determine whether a 7-week course of daily brivaracetam increases parietal operculum brain connectivity. The objective of this exploratory aim is to assess the effect of a 7-week course of brivaracetam treatment on parietal operculum activation and connectivity in SCI. We will 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. To achieve this aim, we will test the working hypothesis that brivaracetam increases parietal operculum activation and connectivity compared to placebo, using rsfMRI, task-based fMRI, and a validated image processing protocol. We will also examine changes in network connectivity and brain activity in the insula, because of its concurrent reported importance for neuropathic pain in SCI. We will assess the association between functional connectivity of the parietal operculum and the insula and change in pain intensity in response to brivaracetam treatment.
Specific Aim 3: Determine whether baseline microRNA-485 levels are associated with response to brivaracetam treatment. The objective of this exploratory aim is to assess microRNA expression as a potential predictive biomarker of response to brivaracetam treatment. To achieve this, we will test the working hypothesis that baseline circulating miR-485 levels predict change in pain intensity in response to brivaracetam treatment. To test this, we will use Next-Generation sequencing. We will assess miR-485 levels at baseline and after a three-month treatment course.
Significance of Research Question/Purpose:
There is currently no effective pharmacological treatment for severe neuropathic pain in SCI. Identification of an oral medication that is effective, safe, and well tolerated would represent a major improvement in the clinical approach to neuropathic pain in SCI. Additionally, there are no validated predictive biomarkers of response to pharmacological therapy in neuropathic pain after SCI. This work is innovative as it seeks to develop a new, mechanism-based pharmacological intervention for neuropathic pain in SCI. Additionally, this project seeks to identify novel biomarkers of neuropathic pain and response to therapy. Development of a reliable, easy to measure biomarker that distinguishes responders from non-responders would dramatically improve clinical care for this condition. Successful completion of this work will rapidly lead to larger clinical trials testing drug efficacy and validating novel predictive biomarkers of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: brivaracetamDrug 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 | Placebo comparator | Drug: PlaceboParticipants with severe neuropathic pain will receive placebo drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age or older
- Injured for \> 3 months
- Completed inpatient rehabilitation and living in the community
- Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3-10) for three months or more
- For people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly).
Key exclusion criteria (16 listed)
- Progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
- Active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin.
- Brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent
- Pregnancy or lactation
- Epilepsy or active treatment for seizure disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brivaracetamDrug 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. | Drug | Experimental group |
| PlaceboParticipants will receive placebo drug | Drug | Control group |
Primary outcome
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity
Time frame: 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.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Neuropathic Pain
Time frame: 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.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Intensity Averaged Over All Pain Sites
Time frame: 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.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Day-to-Day Pain Interference
Time frame: 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.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Mood
Time frame: 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.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Pain Interference With Sleep
Time frame: 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.
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Composite Pain Interference
Time frame: 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.
Change in Operculum Brain Connectivity
Time frame: 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.
microRNA-485 Levels
Time frame: baseline
use Next-Generation sequencing to assess miR-485 levels
microRNA-485 Levels
Time frame: 7 weeks
use Next-Generation sequencing to assess miR-485 levels
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Battaglino, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing brivaracetam in people with Spinal Cord Injuries and Neuropathic Pain, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The International Spinal Cord Injury Pain Data Set (ISCIPBDS) (Version 2.0) - Change in Average Worst Neuropathic Pain Intensity (time frame: 7 Weeks Post Intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.