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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I experience severe, almost constant pain.
Select...
I have finished inpatient rehab and live at home.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brief Pain Inventory
Change in Satisfaction with Life Scale (SWLS)
Secondary outcome measures
Change in Periaqueductal Gray Activity
Other outcome measures
miRNA in Treatment Group
Side effects data
From 2022 Phase 3 trial • 449 Patients • NCT030836655%
Nasopharyngitis
1%
Dizziness
1%
Hyponatraemia
1%
Cervicogenic headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
BRV 200 mg/Day to OLTP BRV
Placebo
BRV 50 mg/Day
BRV 200 mg/Day
BRV 50 mg/Day to OLTP BRV
Placebo 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
~4510
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,588,272 Total Patients Enrolled
Leslie Morse, DOStudy DirectorUniversity of Minnesota
2 Previous Clinical Trials
146 Total Patients Enrolled
Scott Falci, MDPrincipal InvestigatorSwedish Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate if you are allergic to brivaracetam or pyrrolidine derivatives, or if you have metal implants, bullet fragments, or certain medical devices that are not compatible with MRI scans.I have a brain injury that affects my ability to follow instructions.I have been diagnosed with syringomyelia.I experience severe, almost constant pain.I have epilepsy.My liver or kidneys are not working properly.You have a spinal cord injury.I have finished inpatient rehab and live at home.My spinal cord injury has worsened due to scarring.I've tried other pain relief methods without success but can continue my current medications like spasmolytics or opioids during the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Brivaracetam Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research effort actively recruiting participants?
"As per the clinicaltrials.gov listing, this research program is currently open to recruitment. The posting was initially uploaded on February 1st 2021 and modified for accuracy lastly on February 25th 2022."
Answered by AI
How many individuals are participating in this experiment at its most comprehensive level?
"Affirmative. According to information found on clinicaltrials.gov, this study is presently searching for individuals to participate in the trial which was initially posted on February 1st 2021 and last updated on February 25th 2022. A total of 20 participants are required from 2 locations."
Answered by AI
Is this experimental research new to the medical field?
"Brivaracetam has been under scientific scrutiny since 2017, when UCB Biopharma S.P.R.L. sponsored its first trial of 227 patients; this eventually led to the drug's Phase 3 approval in 2021. As of now, 6 ongoing medical studies are taking place across 18 cities and 16 nations around the world."
Answered by AI
What previous studies have utilized Brivaracetam?
"The initial clinical trial of Brivaracetam was inaugurated in 2017, with 18337 studies concluded since then. Presently, 6 trails are still being conducted primarily out of Englewood in Colorado."
Answered by AI
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