Phase 2
Completed N=24
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT04379011 ↗
Enrolled (actual)
24
Serious AEs
5.0%
Results posted
Apr 2025
Primary outcomePrimary: Brief Pain Inventory, Worst Pain — 8.9; 9.7 score on scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory, Worst Pain |
8.1; 7.8 | — |
| PRIMARY Brief Pain Inventory, Least Pain |
5.6; 4.7 | — |
| PRIMARY Brief Pain Inventory, Average Pain |
6.4; 7 | — |
| PRIMARY Satisfaction With Life Scale (SWLS) |
18.3; 19.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04379011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.