An investigational migraine treatment, ALD303, was safe and showed promising signs for efficacy in a proof-of-concept study.
There were no safety concerns noted for an intravenous dose of ALD403 1,000 mg in patients with migraine, according to the results of the randomized, double-blind, placebo-controlled phase 2 trial that assessed the safety, tolerability and efficacy of the drug for migraine prevention.
ALD403 is a genetically-engineered antibody to calcitonin gene-related peptide, which is integral to the pathophysiology of migraine. In a study published in The Lancet Neurology, researchers randomly assigned 163 subjects with an intravenous dose of ALD403 1,000 mg (n=81) or placebo (n=82) and assessed safety after 12 weeks and the efficacy endpoint between weeks five through eight for migraine frequency.
Of the patients receiving the intravenous dose of ALD403, 57% experienced adverse events, compared with 52% of the control group. Adverse events included upper respiratory tract infection, urinary tract infection, fatigue and nausea and vomiting. The researchers observed no differences in vital signs or laboratory data between either group.
Among the ALD403 group, the mean change in migraine days from baseline was −5.6 compared with −4.6 for the control group.
There were also no serious safety concerns with the use of an intravenous dose of ALD403 1,000 mg in patients with five to 14 migraine days in a 28-day period, the researchers noted.
"This study also provides preliminary evidence for the efficacy of ALD403 in the preventive treatment of migraine in patients with a high monthly frequency of migraine days," the researchers wrote.
This study tests the safety, tolerability and efficacy of an intravenous dose of ALD403, a genetically-engineered anti-CGRP, for the prevention of migraine.
In the study, published in The Lancet Neurology, David W. Dodick, MD, of the Mayo Clinic in Arizona, and colleagues, administered either 1,000 mg dose of ALD403 or placebo to 163 randomly-assigned patients aged 18 to 55 years who had five to 14 migraine days per 28-day period to assess the drug’s safety, tolerability, and efficacy.