Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

Phase 1

Completed

Conditions: Spinal Cord Injuries

Interventions: Drug: Brivaracetam
Other: Placebo

Registration Number: NCT04379011

Lead Sponsor: University of Minnesota

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivaracetam Group	Brivaracetam	Participants in this arm will receive the investigational drug, Brivaracetam.
Control Group	Placebo	Participants in this arm will receive a placebo.

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory, Worst Pain	3 months	The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Brief Pain Inventory, Least Pain	3 months	The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Brief Pain Inventory, Average Pain	3 months	The Brief Pain Inventory (BPI) contains 11 numeric rating scales that measure pain intensity and the effect of the pain on a participant's ability to function during various activities of daily living. Each of the 11 scales is rated from 0 (no pain/does not interfere) to 10 (severe pain/completely interferes). Total scores range from 0-110, with higher scores indicating greater pain and interference on daily activities.
Satisfaction With Life Scale (SWLS)	3 months	The satisfaction with life scale contains 5 items designed to measure global cognitive judgments of life satisfaction. Each of the 5 items is rated on a 7-point Likert scale from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life.

Secondary Outcome Measures

Name	Time	Method
Change in Periaqueductal Gray Activity	baseline, 3 months	Periaqueductal gray activity is measured by fMRI (functional magnetic resonance imaging). Outcome is reported as the change in bold signal (a unitless measure) in the targeted area.

Trial Locations

Locations (2): University of Minnesota School of Medicine
🇺🇸
Minneapolis, Minnesota, United States
Swedish Hospital
🇺🇸
Englewood, Colorado, United States