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A New Drug Has Potential To Prevent Migraine

A new phase 2 trial shows that ALD403, a humanized monoclonal antibody that directly targets calcitonin gene-related peptide (CGRO), is safe and effective in preventing migraine.

The results also showed that drug-related adverse events were relatively short-term, with mild to moderate severity. The study also showed that the drug significantly reduced the average number of days of migraine, and some patients even had no migraine attacks.

Professor David W. Dodick, a neurologist at the Mayo Clinic in Arizona, USA, said: „In more than 30 years of animal preclinical work and human clinical work, this is the most effective target for migraine.“

Urgent need

Migraine is the third most common disease and the seventh most disabling disease in the world. At present, there are few treatments that can effectively prevent migraine.

ALD403 is a monoclonal antibody that selectively binds CGRP, which is the key to the pathophysiology of migraine. In contrast, triptans for acute migraine treatment can reduce circulating cgrp antibody concentrations, but this is not their initial effect.

Professor Dodick pointed out that triptan drugs also have many disadvantages. As agonists, they may be transitionally used in patients who are frequently used. They added that triptan drugs also had many adverse reactions.

The new analysis included 163 adults (average age of about 39) from 26 centers in the United States. Pre-screening patients suffered migraines for more than 12 months, with migraine days ranging from 5-14 days every 3 months. The average headache impact test 6 (HIT-6) score was approximately 64. Patients were randomly assigned to receive intravenous ALD403, 1000 mg or placebo.

In this study, no patients withdrew from the study for lack of efficacy adverse events, although 2 patients in the placebo group and 5 patients in the ald403 migraine group lost follow-up 12 weeks after dosing.

During these 12 weeks, adverse events occurred in 52% of the placebo group and 57% of the treatment group. The most common adverse events in the two groups were upper respiratory and urinary tract infections, fatigue, low back pain, nausea and vomiting, and joint pain. Most adverse events are transient, with mild to moderate severity.

Vital signs and laboratory safety data were similar between the two groups. In this study, patients completed an electronic headache record. Based on these records, the mean number of migraine days at baseline and at 5-8 weeks was: ALD403 group –5.6, placebo group –4.6 (difference, –1.0; 95% confidence interval, –2.0 to 0.1; P = .0306).

Secondary analysis showed that at all time points (4, 8, 12 weeks), more patients in the ALD403 group achieved a 50%, 75%, and 100% reduction in migraine days compared to the placebo group. The treatment group is usually 20% more likely. Of the 143 completed patients, 11 had no migraine attacks—all patients were treated with ALD403.

The researchers noted that HIT-6 scores (changes, ALD403 group -9.9, placebo group -8.1) and migraine life instrument specific quality scores decreased at 8 weeks in both groups. Although the study was unable to detect discrepancies in the reported results of these patients, the authors noted that „these findings are encouraging and provide a rationale for further research.“

Inspiring progress

Noah Rosen, a headache expert and associate professor at the Jewish Medical Center in Long Island, New York, said in Medscape Medical News that he is excited about the emergence of new drugs to prevent migraines.

„Everything we currently use for migraine prevention has been adapted for this purpose or found separately to be effective in preventing migraine. This new drug is the first adjustment to the treatment or design of migraine. This is exciting. “

Current migraine prophylaxis includes beta-blockers (propranolol, timolol), antispasmodics (sodium valproate, topiramate), and botulinum toxin type A (Botox). In addition, there are some well-documented antidepressants, including amitriptyline.

Dr Rosen is also anxiously waiting for new drugs. „They are tired of non-special treatment trials. My patient population is highly educated and looks forward to this drug, but they know they need patience because there are many years to go before it goes on the market.

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