OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis

NCT07221799 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HP-00115908
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 multiple sclerosis. Patients will receive medication to assess safety and tolerability.

Conditions

Multiple Sclerosis; Neuropathic Pain

Outcome Measures

Primary Outcomes (7)

• Cmax

  maximum concentration

  over 10 hours

• Safety

  Full reporting of any adverse events on study drug

  Through week 13

• Cmin

  Minimum concentration

  Over 10 hours

• AUC

  Area under curve

  10 hours

• tmax

  time to maximum concentration

  10 hours

• t 1/2

  time to 1/2 maximum concentration

  10 hours

• blood glucose

  blood glucose during 10 hour pharmacokinetic measurements

  10 hours

Secondary Outcomes (2)

• Change in PROMIS Neuropathic Pain Scale Score

  Through week 13

• Change in the PROMISE Pain Interference Score

  Through week 13

Study Arms (2)

oral extended release glibenclamide

EXPERIMENTAL

1. Stage 1, Pharmacokinetics/Pharmacodynamics: This will be a 5 day, unblinded evaluation while participants receive OER-glibenclamide 2. Stage 2, Safety/Efficacy: This part of the study occurs during weeks 2-13, in 3 successive blocks of 4 weeks each. During this stage, group assignments are randomized, and subjects are blinded as to test-drug vs. placebo. Depending on group assignment, exposure to test-drug may occur early (week-2) or later (week-6). In both groups, exposure to placebo occurs for 4 weeks and exposure to drug occurs for 8 successive weeks.

Drug: glibenclamide

Placebo

PLACEBO COMPARATOR

2\. Stage 2, Safety/Efficacy: This part of the study occurs during weeks 2-13, in 3 successive blocks of 4 weeks each. During this stage, group assignments are randomized, and subjects are blinded as to test-drug vs. placebo. Depending on group assignment, exposure to test-drug may occur early (week-2) or later (week-6). In both groups, exposure to placebo occurs for 4 weeks and exposure to drug occurs for 8 successive weeks.

Drug: Placebo

Interventions

glibenclamide DRUG

oral extended release pill

Also known as: glyburide

oral extended release glibenclamide

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuralgia

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Daniel M Harrison

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kerry Naunton

CONTACT

410 328 1885; knaunton@som.umaryland.edu

Daniel Harrison

CONTACT

410-328-5605; dharrison@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In stage 2, medication will be either placebo or treatment, blinded in appearance. Investigators will not be aware of placebo/treatment assignment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 28, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)