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Completed

NCT Number: NCT04379011

Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Swedish Hospital, Englewood, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brivaracetam

Drug

Escalating brivaracetam dose to 150 mg twice daily for 3 months

Other names: Briviact

Placebo

Other

Placebo twice daily for 3 months

Primary outcomes

  1. Brief Pain Inventory, Worst Pain

    Time frame: baseline

    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.

  2. Brief Pain Inventory, Worst Pain

    Time frame: 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.

  3. Brief Pain Inventory, Least Pain

    Time frame: baseline

    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.

  4. Brief Pain Inventory, Least Pain

    Time frame: 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.

  5. Brief Pain Inventory, Average Pain

    Time frame: baseline

    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.

  6. Brief Pain Inventory, Average Pain

    Time frame: 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.

  7. Satisfaction With Life Scale (SWLS)

    Time frame: baseline

    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.

  8. Satisfaction With Life Scale (SWLS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 7, 2020
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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