NCT04379011

Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DRUG	Brivaracetam	Escalating brivaracetam dose to 150 mg twice daily for 3 months
OTHER	Placebo	Placebo twice daily for 3 months

Timeline

• Start date: 2021-02-01
• Primary completion: 2024-03-31
• Completion: 2024-09-01
• First posted: 2020-05-07
• Last updated: 2025-10-14
• Results posted: 2025-04-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study