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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
oral extended release pill
Placebo
University of Maryland School of Medicine
Baltimore, Maryland, United States
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.
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Time frame: Through week 13