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OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis

Not Yet RecruitingPhase 1

Sponsor: University of Maryland, Baltimore

Conditions: Multiple Sclerosis, Neuropathic Pain

Interventions: glibenclamide, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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, myocardial infarction, or coronary intervention within the past 3 months
4. T2DM treated with insulin or oral medication
5. Blood glucose \< 55 mg/dL at enrollment or immediately prior to administration of study drug or a clinically significant history of hypoglycemia.
6. Known sulfonylurea treatment within 7 days. Sulfonylureas include glyburide/glibenclamide (Diabeta, Glynase); glyburide plus metformin (Glucovance); glimepiride (Amaryl); repaglinide (Prandin); nateglinide (Starlix); glipizide (Glucotrol, GlibeneseR, MinodiabR); gliclazide (DiamicronR); tolbutamide (Orinase, Tolinase); glibornuride (Glutril)
7. Known allergy to sulfa or specific allergy to sulfonylurea drugs
8. Known G6PD enzyme deficiency
9. Pregnancy. Women must be either postmenopausal, permanently sterilized or, if ≤50 years old must have a negative test for pregnancy obtained before enrollment
10. Breast-feeding women who do not agree to stop breastfeeding during Study Drug infusion and for 7 days following the end of Study Drug infusion

Locations (1)

Baltimore, Maryland, United States