Trial | NCT04379011  Report issue

Title

Brivaracetam to Reduce Neuropathic Pain in Chronic Spinal Cord Injury
Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Pilot Clinical Trial

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    24
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.
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.
Study Started
Feb 01
2021
Primary Completion
Mar 31
2024
Anticipated
Study Completion
Mar 31
2024
Anticipated
Last Update
Nov 21
2023

Drug Brivaracetam

Escalating brivaracetam dose to 150 mg twice daily for 3 months

  • Other names: Briviact

Other Placebo

Placebo twice daily for 3 months

Brivaracetam Group Experimental

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

Control Group Placebo Comparator

Participants in this arm will receive a placebo.

Criteria 

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
No Results Posted