A Phase 1 interventional study of glibenclamide and Placebo in Multiple Sclerosis and Neuropathic Pain, sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-10-28.
Sponsored by University of Maryland, Baltimore · Phase 1, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 10 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
oral extended release pill
Also known as: glyburide
Placebo
Cmax
maximum concentration
Time frame: over 10 hours
Safety
Full reporting of any adverse events on study drug
Time frame: Through week 13
Cmin
Minimum concentration
Time frame: Over 10 hours
AUC
Area under curve
Time frame: 10 hours
tmax
time to maximum concentration
Time frame: 10 hours
t 1/2
time to 1/2 maximum concentration
Time frame: 10 hours
blood glucose
blood glucose during 10 hour pharmacokinetic measurements
Time frame: 10 hours
Change in PROMIS Neuropathic Pain Scale Score
The questionnaire uses a standard T-score metric, with a mean of 50 and a standard deviation of 10 for a relevant reference population (often the US general population). Higher scores indicate a greater level of neuropathic pain qualities.
Time frame: Through week 13
Change in the PROMISE Pain Interference Score
The PROMIS Pain Interference (PROMIS-PI) scale is a patient-reported outcome measure that assesses how pain affects daily life, including physical, mental, and social activities, as well as sleep and enjoyment. Scores are typically presented on a T-score metric, where 50 is the U.S. general population mean, with higher scores indicating greater pain interference.
Time frame: Through week 13
Plan to share: No
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University of Maryland, Baltimore