Status:
COMPLETED
Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Lead Sponsor:
University of Minnesota
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 pharmacolog...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04379011
Start Date
February 1 2021
End Date
September 1 2024
Last Update
October 14 2025
Active Locations (2)
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1
Swedish Hospital
Englewood, Colorado, United States, 80113
2
University of Minnesota School of Medicine
Minneapolis, Minnesota, United States, 55455