Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Drug: Brivaracetam; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Swedish Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brivaracetam Group; Participants in this arm will receive the investigational drug, Brivaracetam.	Drug: Brivaracetam; Escalating brivaracetam dose to 150 mg twice daily for 3 months; Other Names: Briviact
Placebo Comparator: Control Group; Participants in this arm will receive a placebo.	Other: Placebo; Placebo twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brief Pain Inventory	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.	baseline, 3 months
Change in Satisfaction with Life Scale (SWLS)	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.	baseline, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Periaqueductal Gray Activity	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.	baseline, 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
miRNA in Treatment Group	Outcome reported as the mean number of copies of the target miRNA at baseline.	baseline

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Study Director: Leslie Morse, DO, University of Minnesota; Principal Investigator: Scott Falci, MD, Swedish Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Neuralgia; Spinal Cord Injuries; Anticonvulsants; Brivaracetam
• Other Study ID Numbers: Morse

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No