Lancet Neurology: Galcanezumab's Safety and Effectiveness in Patients Who Failed to Treat 2-4 Migraine Prevention Drugs (CONQUER): A multicenter, randomized, double-blind, placebo-controlled Phase 3b trial.

Migraines are neurological disorders characterized by severe intermittent headaches, accompanied by symptoms such as nausea, vomiting, fear of sound and fear of light.
migraines are the second leading cause of disability, according to the 2016 Global Disease, Injury and Risk Factors Study.
, although preventive medications for migraines can be used to reduce the frequency of migraine attacks, many patients do not respond to or cannot tolerate these treatments.
study reviewing the treatment of migraine patients in France, Germany, Japan and the United States found that 43 percent of migraine preventive medication patients had a history of drug failure or drug replacement.
side effects and lack of efficacy are the most common causes of drug suspension in patients with developing or chronic migraines who are receiving oral preventive treatment.
When migraines are not adequately controlled, their negative impact on patient function increases, leading to a decline in productivity at work, school and at home, loss or restriction of family and social activities, overall decline in quality of life and increased medical costs.
, new, more effective and better tolerance treatments may help improve these outcomes, especially for patients who have not previously benefited from multiple migraine prevention medications.
our goal is to assess the safety and effectiveness of galcanezumab, an antidebody of anticalcullin gene-related peptides, for migraine patients who do not benefit from class 2 to 4 preventive drugs.
Method: This is a multi-center, randomized, double-blind, placebo-controlled Phase 3b trial conducted in 64 locations (hospitals, clinics or research centers) in 12 countries (Belgium, Canada, Czech Republic, France, Germany, Hungary, Japan, Netherlands, Korea, Spain, United Kingdom and United States).
patients aged 18-75 have intermittent or chronic migraines, which occur before the age of 50.
the past 10 years, a lack of effectiveness or toerability, or both, has been documented as a failure of preventive drugs in the 2-4 category.
patients were randomly treated with 120 mg of subsethtic placebo or galcanezumab (240 mg load dose, two 120 mg injections) at a 1:1 scale for 3 months.
patients who received a placebo were also given two injections during the first dose for cover-up purposes.
systoticization is done through computer-generated random sequences, layered by country and migraine frequency by country and migraine frequency (low frequency seizure migraines, 4-8 days per month migraines; frequent migraines, 8-14 days of migraines per month, less than 15 days per month; chronic migraines, at least 8 migraine days per month, at least 15 headache days per month).
the main endpoint was an overall average change in the number of migraine days per month compared to the baseline during 3 months of treatment for all patients who were randomly assigned and received at least one dose of the study drug.
: This study shows that galcanezumab is safe and effective for patients with seizure migraines or chronic migraines who have a history of failure to take preventive medication for migraines.
Galcanezumab not only showed strong results, including reducing the number of migraine days by at least 75% and 100% per month, but also improved patient function, reduced migraine-related disabilities and good tolerance.
Mulleners, Wim M et al. Safety and efficacy of galcanezumab in patients for whom previous migraine minute from from from four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. The Lancet Neurology, Volume 19, Issue 10, 814 - 825MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce, and any media, website or individual must indicate "Source: Mays Medicine" when reprinted.
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