University of Maryland, Baltimore
This is an early phase safety evaluation of the use of oral extended release (OER) glibenclamide, which is otherwise known as glyburide, for use as a treatment for neurologic pain in people with multiple sclerosis. Patients will receive medication to assess safety and tolerability.
This is a 2-stage pilot study of the pharmacodynamics and clinical effects of OER glibenclamide in MS patients with neuropathic pain. This pilot study will include 10 subjects. In Stage 1 of the study, which will last 5 days, unblinded subjects will take test-drug twice daily each day and participate in PK determinations. Successful completion of this Stage will establish the ability of a subject to safely tolerate the test-drug. In Stage 2 of the Study, which will last 3 months, blinded subjects who have demonstrated the ability to safely tolerate the test-drug will be asked to evaluate its c…
Inclusion Criteria: 1. Age 18-65 2. Diagnosis of multiple sclerosis per the 2017 Revised McDonald Criteria 3. Score of ≥ 19 on the painDETECT questionnaire Exclusion Criteria: 1. Severe renal disorder from the patient's history (e.g., dialysis) or eGFR of \< 30 ml/min.1.73m2 2. Severe liver disease, or ALT \> 3 times upper limit of normal or bilirubin \>2 times normal 3. Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc \> 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myoc…
oral extended release pill
Placebo
Arctuva estimate
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