Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

• ClinicalTrials.gov Identifier: NCT04379011
• Recruitment Status: Active, not recruiting
• First Posted: May 7, 2020
• Last Update Posted: December 22, 2022
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Colorado

Swedish Hospital

Englewood, Colorado, United States, 80113

United States, Minnesota

University of Minnesota School of Medicine

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

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

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT04379011
• Other Study ID Numbers: Morse
• First Posted: May 7, 2020
• Last Update Posted: December 22, 2022
• Last Verified: December 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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