Brivaracetam for Neuropathic Pain in SCI

Overseen By Angela Philippus

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Minnesota

Must not be taking: Rifampin, Carbamazepine, others

Disqualifiers: Epilepsy, Drug addiction, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether brivaracetam, an antiepileptic drug, can reduce severe neuropathic pain in people with spinal cord injuries. Neuropathic pain is difficult to treat and often resists usual medications, so researchers hope brivaracetam can make a difference. Participants will receive either brivaracetam or a placebo to determine if pain levels improve noticeably. Those living with spinal cord injuries for over three months and experiencing persistent pain may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that interact with brivaracetam, such as rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin. The trial does not specify a washout period, but you should discuss your current medications with the study team.

Is there any evidence suggesting that brivaracetam is likely to be safe for humans?

Research has shown that brivaracetam is generally safe and well-tolerated for treating nerve pain in people with spinal cord injuries. Studies have found that patients using brivaracetam for this type of pain reported few serious side effects, indicating that the treatment can be used safely over time. For concerns about possible side effects or how this medication might affect you, consult the trial team or your doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for neuropathic pain in SCI?

Brivaracetam is unique because it offers a fresh approach to managing neuropathic pain in spinal cord injury (SCI). Unlike many current treatments, which often focus on general pain relief through medications like gabapentin or pregabalin, brivaracetam targets specific neural pathways by modulating synaptic vesicle protein 2A (SV2A). This targeted mechanism may provide more effective pain relief with potentially fewer side effects. Researchers are excited about brivaracetam because it could offer SCI patients a more precise and potentially faster-acting solution for their debilitating pain.

What evidence suggests that brivaracetam might be an effective treatment for neuropathic pain in SCI?

Research has shown that brivaracetam, which participants in this trial may receive, might help treat nerve pain in people with spinal cord injuries. Studies suggest that this drug targets a protein called SV2A, believed to play a role in pain signals. Early results indicate that brivaracetam could reduce severe pain below the injury and enhance brain connections related to pain. Although initial studies confirmed the drug's safety and practicality, more information is needed to establish its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Ricardo Battaglino, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

For people of child-bearing potential: currently practicing an effective form of two types of birth control (defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly).

I have had chronic nerve pain for over three months.

I have been injured for more than 3 months.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brivaracetam or placebo for neuropathic pain management

12 weeks

Regular visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brivaracetam
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 Intervention

Participants with severe neuropathic pain will receive brivaracetam treatment

Group II: Control group Placebo Group 1 Intervention

Participants with severe neuropathic pain will receive placebo drug

Brivaracetam is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Briviact for:

• Partial-onset seizures with or without secondary generalisation

Approved in United States as Briviact for:

• Focal (partial) onset seizures in epilepsy patients 1 month of age and older

Approved in Canada as Brivlera for:

• Partial-onset seizures with or without secondary generalisation

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Calmare Scrambler Therapy (ST) did not show statistically significant differences in reducing chronic neuropathic pain or improving quality of life compared to sham treatment in a study of 47 military service members.

Despite the lack of measurable efficacy, both active and sham treatments resulted in clinically meaningful pain reductions, and 90% of participants perceived the treatment as a success, highlighting the importance of patient perceptions in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrambler Therapy Treatment: The Importance of Examining Clinically Meaningful Improvements in Chronic Pain and Quality of Life. Nayback-Beebe, A., Panula, T., Arzola, S., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40528843/

Brivaracetam for spinal cord injury-related neuropathic pain These findings suggest safety, tolerability, and feasibility of brivaracetam for treating neuropathic pain in spinal cord injury.

2. jdc.jefferson.edu jdc.jefferson.edu/medfp/494/

Brivaracetam for Spinal Cord Injury-Related Neuropathic Pain CONCLUSIONS: These findings suggest safety, tolerability, and feasibility of brivaracetam for treating neuropathic pain in spinal cord injury.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12173286/

Brivaracetam for spinal cord injury–related neuropathic pain This pilot study suggests the feasibility of conducting a fully powered clinical trial of brivaracetam for treating neuropathic pain in spinal cord injury.

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/study/NCT05639946

Brivaracetam to Reduce Neuropathic Pain in Chronic SCI ... Furthermore, compared to placebo, brivaracetam treatment is hypothesized to reduce severe below-level SCI neuropathic pain and increases parietal operculum ( ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04379011

NCT04379011 | Brivaracetam to Reduce Neuropathic Pain ... Preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in SCI. This randomized, placebo-controlled pilot ...