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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 operculum brain connectivity
change in pain intensity
microRNA-485 levels
Side effects data
From 2021 Phase 1 trial • 12 Patients • NCT0488254083%
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Brivaracetam, a treatment for Spinal Cord Injury (SCI), works by binding to synaptic vesicle protein 2A (SV2A), which is upregulated in the injured spinal cord, thereby stabilizing neurotransmitter release and reducing neuropathic pain. Other treatments include anticonvulsants, cannabinoids, and topical agents, which act through mechanisms like sodium channel blockade and modulation of neurotransmitter receptors.
Understanding these mechanisms is crucial for SCI patients as it helps in tailoring treatments to target specific pain pathways, potentially improving efficacy and minimizing side effects.
Emerging molecular therapeutic targets for spinal cord injury.
Emerging molecular therapeutic targets for spinal cord injury.
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,391 Previous Clinical Trials
1,553,104 Total Patients Enrolled
Ricardo Battaglino, PhDPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of drug addiction.You drink more than four alcoholic drinks in one day (for men) or three drinks in one day (for women), and more than 14 drinks in a week (for men) or 7 drinks in a week (for women).I am not allergic to brivaracetam or similar medications.I have a GI condition that affects how my body absorbs medication.I have had chronic nerve pain for over three months.I have epilepsy or am being treated for seizures.I am 18 years old or older.My kidney function is reduced.My spinal cord condition is worsening due to previous injury or cyst formation.I am not taking medications like rifampin or carbamazepine.I have liver cirrhosis.I do not have any severe health issues that would make me unsuitable for this trial.I have been injured for more than 3 months.I have been injured for over 3 months.You have had thoughts of hurting yourself in the past or currently.I am currently receiving treatment for a mental health condition.I have finished inpatient rehab and live at home.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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