Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury

University of Minnesota (UMN)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Spinal Cord Injuries

Treatments: Drug: Brivaracetam; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04379011

Morse

Details and patient eligibility

About

Spinal cord injury (SCI) is associated with severe neuropathic pain that is often refractory to all pharmacological intervention. Preliminary data suggest brivarecetum is a mechanism-based pharmacological intervention for neuropathic pain in SCI. This randomized, placebo-controlled pilot clinical trial will assess feasibility of a 3-month treatment course with brivarecetum.

Full description

The investigations will assess changes in pain intensity and periaqueductal gray hyperactivity. Baseline periaqueductal gray hyperactivity and microRNA levels will be measured as potential biomarkers of response to treatment. These preliminary findings will be used to design larger clinical trials to establish efficacy of brivarecetum to treat neuropathic pain in SCI.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Spinal cord injury (SCI)
• Participants must have completed inpatient rehabilitation and are living in the community
• Participant who have severe below-level neuropathic pain (daily average 9/10 or 10/10)
• Participants must have tried and failed to achieve adequate pain relief with the use of other drugs (i.e treatment failed to decrease their pain below a level of 9) and can continue to take spasmolytics, pregabalin, gabapentin, and opioids in unchanged dosing throughout the trial

Exclusion criteria

• Pprogressive myelopathy secondary to posttraumatic cord tethering
• Syringomyelia
• Brain injury limiting the ability to follow directions
• Pregnancy or lactation
• Epilepsy
• Impaired liver or renal function
• Contraindications to brivaracetam or pyrrolidine derivatives including allergy, or contraindications to MRI including retained bullet fragments, noncompatible metal implants, and implanted devices such as baclofen pumps

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Brivaracetam Group

Experimental group

Description:

Participants in this arm will receive the investigational drug, Brivaracetam.

Treatment:

Drug: Brivaracetam

Control Group

Placebo Comparator group

Description:

Participants in this arm will receive a placebo.

Treatment:

Other: Placebo