According to the Migraine Research Foundation, migraines affect 36 million people in the U.S. In addition to a throbbing pain on the side of the head, migraines are often accompanied by visual disturbances, nausea, vomiting, dizziness and extreme sensitivity to sound, light, touch and smell. Most available treatments, including Imitrex, aim to stop or lessen migraine pain once it has started. There are also preventive migraine treatments on the market, Botox being the most common. Unfortunately, Botox regimen requires multiple injections at various points on the head and neck every 12 weeks.
The good news is that several companies are actively working on bringing new preventive treatments to the market.
One of the promising compounds is ALD403, being developed by Alder, a Seattle-based biopharmaceutical company. The drug targets a small protein involved in the transmission of migraine pain. According to Alder’s CEO, the company is working on two types of ALD403-based treatments: the IV infusion, which will need to be administered once every four months, and a self-administered shot, intended to be used monthly.
The results of initial clinical trials are promising. As reported by Lancet Neurology last year, in a pilot Phase 2 study of ALD403 with 163 patients suffering from five to fourteen migraine days a month, 60% of participants reduced migraine days by at least half and 15% had no migraine days at all during the 12-week trial.
Yet in order to obtain FDA approval, more clinical trials are necessary. In 2015 Alder launched a more extensive Phase 2b trial. The objective of the trial is to evaluate the effectiveness and safety of four different dose levels of ALD403 when administered to participants who suffer from chronic migraines (15 or more days per month).
We, at Boston Clinical Trials, are excited to be a part of this new study. If you’d like to learn more about the study, which offers free study-related care, free medications, and compensation to participants, please call us at (617) 477-4868 or visit us online.