Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

NCT04379011 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: Morse
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (8)

• Brief Pain Inventory, Worst Pain

  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

• Brief Pain Inventory, Worst Pain

  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.

  3 months

• Brief Pain Inventory, Least Pain

  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

• Brief Pain Inventory, Least Pain

  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.

  3 months

• Brief Pain Inventory, Average Pain

  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

• Brief Pain Inventory, Average Pain

  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.

  3 months

• 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

• 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.

  3 months

Study Arms (2)

Brivaracetam Group

EXPERIMENTAL

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

Drug: Brivaracetam

Control Group

PLACEBO COMPARATOR

Participants in this arm will receive a placebo.

Other: Placebo

Interventions

Brivaracetam DRUG

Escalating brivaracetam dose to 150 mg twice daily for 3 months

Also known as: Briviact

Brivaracetam Group

Placebo OTHER

Placebo twice daily for 3 months

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

Swedish Hospital

Englewood, Colorado, 80113, United States

Location

University of Minnesota School of Medicine

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

The protocol did not allow for assessment of pain scores prior to or after the intervention.

Results Point of Contact

• Title: Dr. Ricardo Battaglino
• Organization: University of Minnesota

rbattagal@umn.edu

612-625-2661

Study Officials

• Leslie Morse, DO

  University of Minnesota

  STUDY DIRECTOR

• Scott Falci, MD

  Swedish Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: February 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: September 1, 2024
• Last Updated: October 14, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-09

Locations

US (2)