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

An Image describing Neuropathic Pain

UMN IRB #: STUDY00010959

ClinicalTrials.gov # NCT04379011

To get more information or apply to enroll in this study please complete the form HERE.

Study participation can be in-person or fully remote, and will last 3 months. There will be 3 study visits, and we will ask you to take the investigational drug or a placebo. There is a 50/50 chance of receiving the investigational drug or placebo pill (has no drug, a sugar pill) and you will not know which one you will receive. You will be compensated up to $350 for your complete participation.

 

Tags
Spinal Cord Injury, Research, Pain, Neuropathic Pain, Clinical Trial

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Study Personnel

Principal Investigator: Dr. Leslie Morse, DO

Co-Investigator: Ricardo Battaglino, PhD

Data Analyst: Nguyen Nguyen 

Study Coordinator: Tiffany Elliott, MA, OTR/L

Study Coordinator: Brian DeVries

Study Coordinator: Tegan Carr

Study Coordinator: Rob Wudlick 

Study Contact Information

For interest in study participation, please use this survey HERE.

Other forms of contact include:
Email: [email protected]

Phone: (612)301-3072 

Inclusion/ Exclusion Criteria

INCLUSION CRITERIA:

  • 18 years of age or older
  • Completed inpatient rehabilitation and living in the community
  • Ongoing severe below-level neuropathic pain (daily average 9/10 or 10/10)
  • Tried and failed to achieve adequate pain relief with the use of other drugs (previous pain management drugs failed to decrease their pain below a self-reported level of 9 out of 10)
  • For people of Child-bearing potential: Currently practicing an effective form 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)

EXCLUSION CRITERIA:

  • Progressive myelopathy secondary to posttraumatic cord tethering or syringomyelia
  • Active use of drugs known to interact with brivaracetam: rifampin, carbamazepine, sodium oxybate, buprenorphine, propoxyphene, levetiracetam, and phenytoin.
  • Brain injury or cognitive impairment limiting the ability to follow directions or provide informed consent
  • Pregnancy or lactation
  • Epilepsy or active treatment for seizure disorder
  • Past or current suicidality
  • Active treatment for psychiatric disease
  • Drug addiction
  • Moderate or heavy alcohol intake (up to four alcoholic drinks for men and three for women in any single day, and a maximum of 14 drinks for men and 7 drinks for women per week)
  • Hepatic cirrhosis, Child-Pugh grades A, B, and C
  • Impaired renal function
  • Contraindications to brivaracetam or pyrrolidine derivatives including allergy
  • Active clinically significant disease (e.g., renal, hepatic, neurological, cardiovascular, pulmonary, endocrine, psychiatric, hematologic, urologic, or other acute or chronic illness) that, in the opinion of the investigator, would make the patient an unsuitable candidate for this trial.
  • History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of brivaracetam
  • Use of any investigational drug 30 days prior to enrollment in this study.