Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine
| العنوان: | Randomized controlled trial of an oral CGRP receptor antagonist, MK-0974, in acute treatment of migraine |
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| المؤلفون: | T W, Ho, L K, Mannix, X, Fan, C, Assaid, C, Furtek, C J, Jones, C R, Lines, A M, Rapoport, Randal, Von Seggern |
| المصدر: | Neurology. 70:1304-1312 |
| بيانات النشر: | Ovid Technologies (Wolters Kluwer Health), 2007. |
| سنة النشر: | 2007 |
| مصطلحات موضوعية: | Adult, Male, Time Factors, Migraine Disorders, Administration, Oral, Calcitonin gene-related peptide, Placebo, law.invention, Calcitonin gene-related peptide receptor antagonist, Double-Blind Method, Randomized controlled trial, Calcitonin Gene-Related Peptide Receptor Antagonists, law, medicine, Humans, Telcagepant, Dose-Response Relationship, Drug, business.industry, Imidazoles, Azepines, medicine.disease, Interim analysis, Rizatriptan, Migraine, Anesthesia, Female, Neurology (clinical), business, Receptors, Calcitonin Gene-Related Peptide, medicine.drug |
| الوصف: | Objective: To determine an effective and tolerable dose of a novel oral calcitonin gene-related peptide (CGRP) receptor antagonist, MK-0974, for the acute treatment of migraine. Methods: Randomized, double-blind, parallel-group, clinical trial with a two-stage, adaptive, dose-ranging design. Patients were allocated to treat a moderate or severe migraine attack with MK-0974 (25, 50, 100, 200, 300, 400, or 600 mg), rizatriptan 10 mg, or placebo taken orally. The primary endpoint was pain relief (reduction to mild or none) 2 hours after dosing. Secondary endpoints included pain freedom at 2 hours and sustained pain relief at 24 hours. A prespecified, blinded, automated interim analysis was used to discontinue randomization to less effective doses. Results: Per the adaptive study design, the four lowest MK-0974 groups (25, 50, 100, 200 mg) were discontinued due to insufficient efficacy. For the remaining treatment groups, the estimated pain relief proportions at 2 hours were 300 mg (n = 38) 68.1%, 400 mg (n = 45) 48.2%, 600 mg (n = 40) 67.5%, rizatriptan 10 mg (n = 34) 69.5%, and placebo (n = 115) 46.3%. The prespecified primary efficacy hypothesis test, which compared the average 2-hour pain relief response proportion of the combined 300, 400, and 600 mg MK-0974 groups to placebo, was significant ( P = 0.015). A generally similar efficacy pattern was seen for other endpoints. MK-0974 was generally well tolerated and there did not appear to be an increase in adverse events with increasing dose. Conclusions: The novel, orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, MK-0974, was effective and generally well tolerated for the acute treatment of migraine. |
| تدمد: | 1526-632X 0028-3878 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac31fd31e6bd3ccff46010384a72a160Test https://doi.org/10.1212/01.wnl.0000286940.29755.61Test |
| رقم الانضمام: | edsair.doi.dedup.....ac31fd31e6bd3ccff46010384a72a160 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1526632X 00283878 |
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