Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

NCT ID: NCT04379011

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2024-09-01

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Brivaracetam Group

Participants in this arm will receive the investigational drug, Brivaracetam.

Group Type: EXPERIMENTAL

Brivaracetam

Intervention Type: DRUG

Escalating brivaracetam dose to 150 mg twice daily for 3 months

Control Group

Participants in this arm will receive a placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo twice daily for 3 months

Interventions

Brivaracetam

Escalating brivaracetam dose to 150 mg twice daily for 3 months

Intervention Type: DRUG

Placebo

Placebo twice daily for 3 months

Intervention Type: OTHER

Other Intervention Names

Briviact

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leslie Morse, DO

Role: STUDY_DIRECTOR

University of Minnesota

Scott Falci, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Hospital

Locations

Swedish Hospital

Englewood, Colorado, United States

University of Minnesota School of Medicine

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Morse

Identifier Type: -

Identifier Source: org_study_id