Brivaracetam to Reduce Neuropathic Pain in Chronic SCI: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Launched by UNIVERSITY OF MINNESOTA · Dec 5, 2022

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years of age or older
• • Injured for \> 3 months
• • Completed inpatient rehabilitation and living in the community
• • Chronic sublesional neuropathic pain defined as persistent pain (VAS grade 3-10) for three months or more
• • 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).
• 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 (GFR\<60ml/minute)
• • 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
• • Enrollment in another clinical trial.

Trial Officials