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

Not yet recruitingPhase 1MS (type not specified)NCT07221799

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Glyburide

    Sulfonylurea receptor 1, Kir6.2 blocker

Placebo

  • Placebo

What it measured

Main measures

  • Cmax

    over 10 hours

    How the body handles the medicine

  • Safety

    Through week 13

    Safety

  • Cmin

    Over 10 hours

  • AUC

    10 hours

    How the body handles the medicine

  • tmax

    10 hours

  • t 1/2

    10 hours

  • blood glucose

    10 hours

    How the body handles the medicine

Other measures (2)

  • Change in PROMIS Neuropathic Pain Scale Score

    Through week 13

    Pain

  • Change in the PROMISE Pain Interference Score

    Through week 13

    PainMood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Sept 2026

    2. Main results due

      Sept 2028

    3. Finished

      Sept 2029

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