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Not yet recruiting NCT07221799

OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis

Phase I Interventional Multiple Sclerosis Neuropathic Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: glibenclamide, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Neuropathic Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study of the Pharmacodynamics and Clinical Effects of Oral Extended Release (OER) Glibenclamide in Multiple Sclerosis Patients With Neuropathic Pain

Overview

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.

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, 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 clinical efficacy specifically with regard to neuropathic pain. By using a 3-block/on-off design with blinding, each subject will serve as their own control during the Stage-2 efficacy part of the study.

Interventions

  • Drug glibenclamide
    oral extended release pill
  • Drug Placebo
    Placebo

Primary outcome measures

  • Cmax [Time frame: over 10 hours]
  • Safety [Time frame: Through week 13]
  • Cmin [Time frame: Over 10 hours]
  • AUC [Time frame: 10 hours]
  • tmax [Time frame: 10 hours]
  • t 1/2 [Time frame: 10 hours]
  • blood glucose [Time frame: 10 hours]
Secondary outcome measures (2)
  • Change in PROMIS Neuropathic Pain Scale Score [Time frame: Through week 13]
  • Change in the PROMISE Pain Interference Score [Time frame: Through week 13]

Eligibility criteria

Inclusion criteria

  • Age 18-65
  • Diagnosis of multiple sclerosis per the 2017 Revised McDonald Criteria
  • Score of ≥ 19 on the painDETECT questionnaire

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Maryland School of Medicine — Baltimore

Identifiers

NCT: NCT07221799 · HP-00115908

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗