Apply to Trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

44 Participants Needed

Brivaracetam for Neuropathic Pain in SCI

Overseen ByAngela 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 DataThis treatment has passed at least one previous human trial

Trial Summary

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.

How is the drug Brivaracetam unique for treating neuropathic pain in spinal cord injury?

Brivaracetam is unique because it is primarily an anticonvulsant, which means it is usually used to treat seizures, but it is being explored for neuropathic pain due to its potential to modulate nerve activity differently than traditional pain medications. This approach is novel compared to existing treatments, which often have limited effectiveness and frequent side effects.¹ ² ³ ⁴ ⁵

What is the purpose of this trial?

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.

Research Team

Ricardo Battaglino, PhD

Principal Investigator

University of Minnesota

Eligibility Criteria

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.

See 2 more

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.

See 13 more

Timeline

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

Treatment Details

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.

Participant Groups

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

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

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]