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Antiepileptic

Brivaracetam for Neuralgia Due to Spinal Cord Injury

Phase 1 & 2
Waitlist Available
Led By Scott Falci, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have severe below-level neuropathic pain (daily average 9/10 or 10/10)
Participants who have completed inpatient rehabilitation and are living in the community
Must not have
Brain injury limiting the ability to follow directions
Syringomyelia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months

Summary

This trial will assess the feasibility of a 3-month treatment course with the drug brivarecetum for people with neuropathic pain associated with spinal cord injury.

Who is the study for?
This trial is for adults with chronic spinal cord injury who suffer from severe neuropathic pain that hasn't improved with other drugs. They must have completed inpatient rehab, live in the community, and can keep taking certain medications like spasmolytics during the trial. It's not for those with progressive myelopathy, syringomyelia, brain injuries affecting comprehension, pregnant or breastfeeding individuals, epilepsy patients, or those with liver/renal issues or allergies to brivaracetam.
What is being tested?
The study tests Brivaracetam—a potential new treatment for neuropathic pain in people with spinal cord injury—against a placebo over three months. Participants are randomly assigned to receive either Brivaracetam or a placebo pill without knowing which one they're getting.
What are the potential side effects?
Brivaracetam may cause side effects such as sleepiness, dizziness, fatigue, nausea and vomiting. Since it affects the nervous system directly, some people might also experience mood changes or skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experience severe, almost constant pain.
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I have finished inpatient rehab and live at home.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a brain injury that affects my ability to follow instructions.
Select...
I have been diagnosed with syringomyelia.
Select...
I have epilepsy.
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My liver or kidneys are not working properly.
Select...
My spinal cord injury has worsened due to scarring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Brief Pain Inventory
Change in Satisfaction with Life Scale (SWLS)
Secondary study objectives
Change in Periaqueductal Gray Activity
Other study objectives
miRNA in Treatment Group

Side effects data

From 2022 Phase 3 trial • 449 Patients • NCT03083665
19%
Somnolence
14%
Dizziness
7%
Nasopharyngitis
5%
Upper respiratory tract infection
5%
Headache
1%
Miscarriage of partner
1%
Pyrexia
1%
Calculus ureteric
1%
Large intestine polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
BRV 200 mg/Day
Placebo
BRV 50 mg/Day
Placebo to OLTP BRV
BRV 50 mg/Day to OLTP BRV
BRV 200 mg/Day to OLTP BRV

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Brivaracetam GroupExperimental Treatment1 Intervention
Participants in this arm will receive the investigational drug, Brivaracetam.
Group II: Control GroupPlacebo Group1 Intervention
Participants in this arm will receive a placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brivaracetam
2019
Completed Phase 3
~4500

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,435 Previous Clinical Trials
1,621,639 Total Patients Enrolled
Leslie Morse, DOStudy DirectorUniversity of Minnesota
2 Previous Clinical Trials
146 Total Patients Enrolled
Scott Falci, MDPrincipal InvestigatorSwedish Hospital

Media Library

Brivaracetam (Antiepileptic) Clinical Trial Eligibility Overview. Trial Name: NCT04379011 — Phase 1 & 2
Spinal Cord Injury Research Study Groups: Brivaracetam Group, Control Group
Spinal Cord Injury Clinical Trial 2023: Brivaracetam Highlights & Side Effects. Trial Name: NCT04379011 — Phase 1 & 2
Brivaracetam (Antiepileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04379011 — Phase 1 & 2
~5 spots leftby Dec 2025
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