Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral extended release glibenclamide | Experimental |
|
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glibenclamide | Drug | oral extended release pill |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through week 13 |
| Change in the PROMISE Pain Interference Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kerry Naunton | Contact | 410 328 1885 | knaunton@som.umaryland.edu | |
| Daniel Harrison | Contact | 410-328-5605 | dharrison@som.umaryland.edu |
| Name | Affiliation | Role |
|---|---|---|
| Daniel M Harrison | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005905 | Glyburide |
| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
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.
Not provided
Not provided
In stage 2, medication will be either placebo or treatment, blinded in appearance. Investigators will not be aware of placebo/treatment assignment.
| Placebo | Drug | Placebo |
|
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. |
| Through week 13 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013450 |
| Sulfones |
| D013457 | Sulfur Compounds |