Status:
NOT_YET_RECRUITING
OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Multiple Sclerosis
Neuropathic Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 multi...
Detailed 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...
Eligibility Criteria
Inclusion
- Age 18-65
- Diagnosis of multiple sclerosis per the 2017 Revised McDonald Criteria
- Score of ≥ 19 on the painDETECT questionnaire
Exclusion
- Severe renal disorder from the patient's history (e.g., dialysis) or eGFR of \< 30 ml/min.1.73m2
- Severe liver disease, or ALT \> 3 times upper limit of normal or bilirubin \>2 times normal
- 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
- T2DM treated with insulin or oral medication
- Blood glucose \< 55 mg/dL at enrollment or immediately prior to administration of study drug or a clinically significant history of hypoglycemia.
- 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)
- Known allergy to sulfa or specific allergy to sulfonylurea drugs
- Known G6PD enzyme deficiency
- Pregnancy. Women must be either postmenopausal, permanently sterilized or, if ≤50 years old must have a negative test for pregnancy obtained before enrollment
- 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
Key Trial Info
Start Date :
September 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07221799
Start Date
September 1 2026
End Date
September 1 2029
Last Update
October 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201