Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Mar 16, 2023
  • participants needed
    20
  • sponsor
    University of Minnesota
Updated on 16 March 2022
pain relief
pregabalin
spinal cord
neuropathic pain
spinal cord disorder

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.

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.

Details
Condition Spinal Cord Injuries
Treatment Placebo, Brivaracetam
Clinical Study IdentifierNCT04379011
SponsorUniversity of Minnesota
Last Modified on16 March 2022

Eligibility

Yes No Not Sure

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
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