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Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT04379011
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Drug: Brivaracetam Other: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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 Name: Briviact

Placebo Comparator: Control Group
Participants in this arm will receive a placebo.
Other: Placebo
Placebo twice daily for 3 months




Primary Outcome Measures :
  1. Change in Brief Pain Inventory [ Time Frame: baseline, 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.

  2. Change in Satisfaction with Life Scale (SWLS) [ Time Frame: baseline, 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 :
  1. Change in Periaqueductal Gray Activity [ Time Frame: 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.


Other Outcome Measures:
  1. miRNA in Treatment Group [ Time Frame: baseline ]
    Outcome reported as the mean number of copies of the target miRNA at baseline.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04379011


Contacts
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Contact: Leslie Morse, DO 612-626-5957 rehablab@umn.edu
Contact: Nguyen Nguyen, MPH nguy4139@umn.edu

Locations
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United States, Colorado
Swedish Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Scott Falci, MD       sfalci@comcast.com   
Contact: Abigail Welch       awelch@craighospital.org   
United States, Minnesota
University of Minnesota School of Medicine Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Leslie R Morse, DO    612-626-5957    morsel@umn.edu   
Contact: Nguyen Nguyen, MPH       nguy4139@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Study Director: Leslie Morse, DO University of Minnesota
Principal Investigator: Scott Falci, MD Swedish Hospital
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04379011    
Other Study ID Numbers: Morse
First Posted: May 7, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Neuralgia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Pain
Neurologic Manifestations
Brivaracetam
Anticonvulsants