A Pilot Study of the Pharmacodynamics and Clinical Effects of Oral Extended Release (OER) Glibenclamide in Multiple Sclerosis Patients With Neuropathic Pain
University of Maryland, Baltimore
Summary
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.
Description
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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugglibenclamide
oral extended release pill
- DrugPlacebo
Placebo
Location
- University of Maryland School of MedicineBaltimore, Maryland