Clinical trial NCT04379011: Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Official title: Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Spinal Cord Injuries
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

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

Primary outcomes:
measure: Brief Pain Inventory, Worst Pain
timeFrame: baseline
measure: Brief Pain Inventory, Worst Pain
timeFrame: 3 months
measure: Brief Pain Inventory, Least Pain
timeFrame: baseline
measure: Brief Pain Inventory, Least Pain
timeFrame: 3 months
measure: Brief Pain Inventory, Average Pain
timeFrame: baseline
measure: Brief Pain Inventory, Average Pain
timeFrame: 3 months
measure: Satisfaction With Life Scale (SWLS)
timeFrame: baseline
measure: Satisfaction With Life Scale (SWLS)
timeFrame: 3 months
Secondary outcomes:
measure: Change in Periaqueductal Gray Activity
timeFrame: baseline, 3 months
Other outcomes:
measure: miRNA in Treatment Group
timeFrame: baseline
Locations:
city: Englewood
country: United States
facility: Swedish Hospital
state: Colorado
city: Minneapolis
country: United States
facility: University of Minnesota School of Medicine
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Leslie Morse, DO
role: STUDY_DIRECTOR
affiliation: Swedish Hospital
name: Scott Falci, MD
role: PRINCIPAL_INVESTIGATOR
References: