Biopharmaceutical company Amgen is currently recruiting eligible patients to test the efficacy and safety of a new drug for migraine prevention.
Migraines are a significant cause of disability in Canada. In the years 2010 to 2011, approximately 2.7 million Canadians reported to have been diagnosed with a migraine – a figure that Statistics Canada suspects to be an underestimation, since many people with migraines do not seek professional help and therefore cannot report a diagnosis.
Characterized by throbbing or pulsating headaches that intensify with physical activity, migraine can be a debilitating disorder with high costs. Enduring other symptoms of nausea, vomiting, and sensitivity to light and sound, individuals suffering from a chronic or an episodic migraine often have a lower quality of life. Families and communities are also affected regarding medical expenses and work productivity due to absence from school or the workplace.
Biopharmaceutical giant Amgen, headquartered in California, USA, is now recruiting participants with a chronic or an episodic migraine to test the efficacy and safety of a new drug currently named AMG 301. Researchers will test the drug – a monoclonal antibody with an undisclosed mechanism of action – against a placebo in this phase 2a, randomized, double-blind study.
For the study, they will primarily look at the change in monthly migraine days from the start of the study. They will calculate the monthly migraine days using the migraine days over the last four weeks of the 12-week treatment period. Other outcomes they will measure include a 50% reduction rate in monthly migraine days from the start of the study, a change in monthly acute migraine-specific medication days from the start of the study, and a change in physical impairment scores from the beginning of the study.
The study, sponsored by Amgen, is looking to enrol 335 eligible participants between the ages of 18 and 60 in locations across North America and Europe. These recruitment locations include the USA, Canada, Austria, Denmark, Finland, Germany, Sweden, and the Czech Republic. The study started on September 6, 2017, and they expect to complete it by August 31, 2018.
Written by Jessica Gelar, HBSc
(1) “Amgen – Clinical Trials – Amgen Trials”. Amgentrials, 2018, http://www.amgentrials.com/amgen/trialsummary.aspx?studyid=20150308. Accessed 3 Apr 2018.
(2) “Prevalence Of Migraine In The Canadian Household Population”.Statistics Canada, 2018, https://www.statcan.gc.ca/pub/82-003-x/2014006/article/14033-eng.htm. Accessed 3 Apr 2018.
(3) “Study To Evaluate The Efficacy And Safety Of AMG 301 In Migraine Prevention – Tabular View – Clinicaltrials.Gov”.Gov, 2018, https://clinicaltrials.gov/ct2/show/record/NCT03238781?recrs=a&type=Intr&map_cntry=CA&phase=1&draw=30&rank=298. Accessed 3 Apr 2018.