Glibenclamide for Neuropathic Pain in Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether glibenclamide, taken as an oral extended-release pill, can safely alleviate nerve pain in people with multiple sclerosis (MS). Participants will receive either the medication or a placebo (a pill with no active ingredient) to help researchers assess glibenclamide's tolerance over time. This trial may suit individuals diagnosed with MS who frequently experience nerve pain. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking any sulfonylurea medications, like glyburide or glipizide, at least 7 days before joining. If you're on these medications, you'll need to stop them to participate.
Is there any evidence suggesting that glibenclamide is likely to be safe for humans?
Research shows that glibenclamide, a drug commonly used for diabetes, is under investigation for its potential to alleviate nerve pain in people with multiple sclerosis. Other research has found glibenclamide to be generally safe for individuals who have had a stroke, with most experiencing no serious side effects.
This trial is in the early stages and primarily examines the safety and tolerability of glibenclamide for people with multiple sclerosis. While previous studies have not identified major safety concerns, this trial aims to determine its safety for this new application.
By participating in early-stage trials, individuals contribute to researchers' understanding of a treatment's safety, despite some remaining uncertainties.12345Why do researchers think this study treatment might be promising for multiple sclerosis?
Most treatments for neuropathic pain in multiple sclerosis, like gabapentin and pregabalin, work by modulating neurotransmitter release. But glibenclamide works differently, targeting a specific pathway involved in inflammation and nerve damage. This unique mechanism of action could offer relief for patients who don't respond well to existing treatments. Researchers are excited because glibenclamide has the potential to not only alleviate pain but also address the underlying nerve damage. Additionally, the extended-release formulation aims to provide consistent pain management throughout the day with potentially fewer side effects.
What evidence suggests that glibenclamide might be an effective treatment for neuropathic pain in multiple sclerosis?
Research has shown that glibenclamide might help with nerve problems by reducing damage to the protective covering of nerves, as observed in animal studies. In this trial, participants will receive either oral extended-release glibenclamide or a placebo. In stroke cases, glibenclamide is considered safe, although it did not prove very effective for that specific condition. Animal studies have found it works well with other treatments, which is encouraging for its use in combination therapies. While direct evidence for its use in nerve pain from multiple sclerosis is limited, the potential of glibenclamide to reduce nerve damage offers hope for managing this type of pain.12456
Who Is on the Research Team?
Daniel M Harrison
Principal Investigator
University of Maryland, Baltimore
Are You a Good Fit for This Trial?
This trial is for adults aged 18-65 with multiple sclerosis who experience nerve pain, as indicated by a score of ≥ 19 on the painDETECT questionnaire. It's not open to those breastfeeding (unless they stop), with allergies to sulfa or sulfonylurea drugs, severe kidney/liver issues, low blood sugar, G6PD deficiency, recent heart problems, or taking certain diabetes medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Stage 1: Pharmacokinetics/Pharmacodynamics
Unblinded evaluation while participants receive OER-glibenclamide to assess safety and pharmacokinetics
Stage 2: Safety/Efficacy
Blinded evaluation of clinical efficacy with a 3-block/on-off design, serving as their own control
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Glibenclamide
Trial Overview
The study tests oral extended release glibenclamide against a placebo in managing neuropathic pain in multiple sclerosis patients. The goal is to evaluate the safety and tolerability of this medication when used for neurological pain relief.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Citations
OER Glibenclamide for Neuropathic Pain in Multiple ...
This is a 2-stage pilot study of the pharmacodynamics and clinical effects of OER glibenclamide in MS patients with neuropathic pain. This pilot ...
Glibenclamide for Neuropathic Pain in Multiple Sclerosis
Glibenclamide. Trial Overview The study tests oral extended release glibenclamide against a placebo in managing neuropathic pain in multiple sclerosis patients.
BIIB093 (IV glibenclamide): an investigational compound for ...
The best neurological outcomes were observed in rats treated with both rtPA and glibenclamide, suggesting synergy. Recent work has elucidated a possible ...
Safety and efficacy of glibenclamide on functional ...
Conclusion: In patients with ischemic or hemorrhagic stroke, glibenclamide demonstrates a favorable safety profile but shows limited efficacy ...
5.
researchgate.net
researchgate.net/figure/Chronic-phase-glibenclamide-reduces-demyelination-in-EAE-White-matter-of-lumbar-spinal_fig2_319450337Chronic phase glibenclamide reduces demyelination in ...
The spinal cords of un-treated EAE mice showed 37.9 ± 5.0% demyelination assessed by LFB, and 26.3 ± 3.4% by MBP.
OER Glibenclamide for Neuropathic Pain in Multiple
The study will collect information on drug levels in the blood, safety (including any adverse events and blood glucose), and changes in ...
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