NCT07221799Not yet recruitingPhase 1
OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis
A Pilot Study of the Pharmacodynamics and Clinical Effects of Oral Extended Release (OER) Glibenclamide in Multiple Sclerosis Patients With Neuropathic Pain
Source: ClinicalTrials.gov · Last updated 28 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 17 Oct 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Multiple sclerosis
- NCT number
- NCT07221799
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 1 Sept 2026 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- T2DM treated with insulin or oral medication
- 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
Other illness
- Known allergy to sulfa or specific allergy to sulfonylurea drugs
Lab values
- 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
- Blood glucose \< 55 mg/dL at enrollment or immediately prior to administration of study drug or a clinically significant history of hypoglycemia.
Age
- Pregnancy. Women must be either postmenopausal, permanently sterilized or, if ≤50 years old must have a negative test for pregnancy obtained before enrollment
Other
- 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 G6PD enzyme deficiency
Who the study is looking for
- Age 18-65
- Diagnosis of multiple sclerosis per the 2017 Revised McDonald Criteria
- Score of ≥ 19 on the painDETECT questionnaire
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Maryland School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.