Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Drug: Brivaracetam
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spinal cord injury (SCI) Participants must have completed inpatient rehabilitation and are living in the community Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10) Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial Exclusion Criteria: Pprogressive myelopathy secondary to posttraumatic cord tethering Syringomyelia Brain injury limiting the ability to follow directions Pregnancy or lactation Epilepsy Impaired liver or renal function Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brivaracetam Group<br>Participants in this arm will receive the investigational drug, Brivaracetam. | Drug: Brivaracetam<br>* Escalating brivaracetam dose to 150 mg twice daily for 3 months<br>* Other names: Briviact;|
| Placebo Comparator: Control Group<br>Participants in this arm will receive a placebo. | Other: Placebo<br>* Placebo twice daily for 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory | 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, 3 months | 
| Change in 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, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Periaqueductal Gray Activity | Periaqueductal gray activity is measured by fMRI (functional magnetic resonance imaging). Outcome is reported as the change in bold signal (a unitless measure) in the targeted area. | baseline, 3 months |