Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Treatments: Brivaracetam

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