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Antiepileptic

Brivaracetam for Neuropathic Pain in SCI

Phase 3
Recruiting
Led By Ricardo Battaglino, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3-10) for three months or more
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial aims to see if a drug called brivaracetam can reduce neuropathic pain in people with spinal cord injury. It also looks at how the drug affects brain activity & circulating molecules.

Who is the study for?
This trial is for adults over 18 who've had a spinal cord injury (SCI) for more than 3 months and suffer from chronic neuropathic pain. They must have completed inpatient rehab, be living in the community, and use two effective birth control methods if of child-bearing potential. Exclusions include brain injuries, other significant health issues, drug addiction, epilepsy, heavy alcohol use, poor kidney function or liver cirrhosis.Check my eligibility
What is being tested?
The study tests brivaracetam's effectiveness against neuropathic pain due to SCI. Participants are randomly assigned to receive either brivaracetam or a placebo without knowing which one they're getting (double-blind). The trial also examines changes in brain connectivity and miRNA levels related to pain intensity with treatment.See study design
What are the potential side effects?
Potential side effects of brivaracetam may include allergic reactions for those sensitive to pyrrolidine derivatives; interactions with certain drugs like rifampin or phenytoin; cognitive changes; mood swings including suicidality; and possibly others not listed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had chronic nerve pain for over three months.
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I am 18 years old or older.
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I have been injured for more than 3 months.
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I have been injured for over 3 months.
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I have finished inpatient rehab and live at home.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
change in operculum brain connectivity
change in pain intensity
microRNA-485 levels

Side effects data

From 2021 Phase 1 trial • 12 Patients • NCT04882540
83%
Dizziness
58%
Somnolence
33%
Diarrhoea
25%
Asthenia
25%
Ataxia
25%
Electrocardiogram QT prolonged
8%
Atrioventricular block first degree
8%
Ventricular extrasystoles
8%
Palpitations
8%
Blood pressure decreased
8%
Haematuria
8%
Leukocyturia
8%
Neutrophilia
8%
Feeling drunk
8%
Vertigo
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brivaracetam

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental groupExperimental Treatment1 Intervention
Participants with severe neuropathic pain will receive brivaracetam treatment
Group II: Control groupPlacebo Group1 Intervention
Participants with severe neuropathic pain will receive placebo drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
brivaracetam
2022
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,461 Total Patients Enrolled
Ricardo Battaglino, PhDPrincipal InvestigatorUniversity of Minnesota

Media Library

Brivaracetam (Antiepileptic) Clinical Trial Eligibility Overview. Trial Name: NCT05639946 — Phase 3
Spinal Cord Injury Research Study Groups: Experimental group, Control group
Spinal Cord Injury Clinical Trial 2023: Brivaracetam Highlights & Side Effects. Trial Name: NCT05639946 — Phase 3
Brivaracetam (Antiepileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639946 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any individuals able to register for this research endeavor currently?

"Contrary to what is posted on clinicaltrials.gov, this particular trial appears not be actively recruiting patients at the moment; it was initially published in January 1st 2023 and updated lastly December 5th 2022. However, there are 503 other medical trials that currently require participants."

Answered by AI

What safety risks are present for individuals in the Experimental group?

"Based on our team's assessment, Experimental group was assigned a 3 due to existing clinical data which demonstrates its effectiveness and the multiple safety studies conducted."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
2023. "Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05639946.
All > Nerve Pain
~27 spots leftby Jan 2028
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