What side effects are associated with this type of intervention?

Common treatments for Spinal Cord Injury (SCI) that involve modulation of synaptic vesicle proteins, such as Brivaracetam, often have side effects including dizziness, fatigue, somnolence, and nausea. Other similar treatments, like gabapentinoids (gabapentin and pregabalin), can cause dizziness, somnolence, peripheral edema, and weight gain. These side effects should be carefully considered when selecting a treatment plan.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting synaptic vesicle protein 2A (SV2A) for Spinal Cord Injury (SCI). Brivaracetam, which is being studied for its potential to reduce neuropathic pain in SCI by modulating SV2A, represents a novel approach. Broadly, FDA-approved treatments for SCI focus on managing symptoms and complications, including pain management, spasticity, and secondary conditions. These treatments often involve a combination of pharmacological agents, physical therapy, and surgical interventions.

What other types of research exist?

Promising alternatives to Brivaracetam for SCI patients include: 1) N-type calcium channel blockers like ω-conotoxins (e.g., MVIIA and CVID) which target Cav2.2 channels and have shown efficacy in neuropathic pain models. 2) Cannabinoid treatments, particularly cannabidiol (CBD), which have shown potential in reducing neuronal excitability and treating related symptoms in various neurological conditions. These alternatives offer different mechanisms of action and have shown promise in clinical studies.

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Antiepileptic

Brivaracetam for Neuropathic Pain in SCI

Phase 3

Waitlist Available

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

Must not have

Contraindications to brivaracetam or pyrrolidine derivatives including allergy

Epilepsy or active treatment for seizure disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing brivaracetam, a medication that may help reduce severe pain in people with spinal cord injuries. It targets a specific protein in the spinal cord that is linked to pain. The study aims to see if this treatment is effective for those who do not respond well to other pain medications.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to brivaracetam or similar medications.

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I have epilepsy or am being treated for seizures.

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I have a GI condition that affects how my body absorbs medication.

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My kidney function is reduced.

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My spinal cord condition is worsening due to previous injury or cyst formation.

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I am not taking medications like rifampin or carbamazepine.

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I have liver cirrhosis.

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I am currently receiving treatment for a mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Atrioventricular block first degree

Ventricular extrasystoles

Palpitations

Blood pressure decreased

Haematuria

Leukocyturia

Neutrophilia

Feeling drunk

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Brivaracetam

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 13Eligibility criteria met

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.