In this randomised, double-blind, placebo-controlled, exploratory, proof-of-concept phase 2 trial, patients aged 18–55 years with five to 14 migraine days per 28-day period were randomly assigned (1:1) via an interactive web response system to receive an intravenous dose of ALD403 1000 mg or placebo. Site investigators, patients, and the sponsor were masked to treatment allocation during the study. The primary objective was to assess safety at 12 weeks after infusion. The primary efficacy endpoint was the change from baseline to weeks 5–8 in the frequency of migraine days, as recorded in patient electronic diaries. Patients were followed up until 24 weeks for exploratory safety and efficacy analyses. Safety and efficacy analyses were done by intention to treat. This study is registered with ClinicalTrials.gov, NCT01772524.
In this randomized, double-blind, placebo-controlled, multicenter trial (ClinicalTrials.gov NCT00797667), patients experiencing 3–14 migraine days during a 4-week baseline were randomized to telcagepant 140 mg, telcagepant 280 mg, or placebo twice daily for 12 weeks. Efficacy was assessed by mean monthly headache days and migraine/probable migraine days (headache plus ≥1 associated symptom). The trial was terminated following a recommendation from the Safety Monitoring Board due to hepatotoxicity concerns. At termination, the planned 660 patients had been randomized, 656 had been treated with ≥1 dose of study medication, and 14 had completed the trial.
In The Lancet Neurology, David Dodick and colleagues1 introduce monoclonal antibodies into the specialty of primary headache therapy. They report findings from a randomised, placebo-controlled, double-blind, phase 2 clinical trial of LY2951742, a neutralising humanised monoclonal antibody against calcitonin gene-related peptide (CGRP), for migraine prevention. The subcutaneous administration of LY2951742 once every 2 weeks reduced the mean number of migraine headache days per 28-day period between baseline and weeks 9–12 (primary endpoint; least-squares mean difference −1·2, 90% CI −1·9 to −0·6; p=0·0030) in a population with a high frequency of migraine; the antibody was also superior to placebo in several secondary endpoints after 12 weeks of treatment.
These results provide preliminary evidence that LY2951742 might be beneficial in migraine prevention and provide support for the role of calcitonin gene-related peptide in the pathogenesis of migraine. Further controlled studies are needed to assess the safety and efficacy of monoclonal calcitonin gene-related peptide antibodies for the preventive treatment of migraine.
In June, Teva of Petach Tikva, Israel, paid $200 million in cash and $625 million in future milestones to acquire Labrys Biologics of San Mateo, California. The Israeli drug maker wanted to get its hands on LBR-101, the biotech’s preventive treatment for migraines and its only asset. LBR-101, a humanized monoclonal a…
Calcitonin gene-related peptide (CGRP) is a well-studied neuropeptide of relevance for migraine pathophysiology. Jugular levels of CGRP are increased during migraine attacks, and intravenous CGRP administration induces migraine-like headache in most individuals with migraine. Several CGRP receptor antagonists (CGRP-RAs) were shown to be effective for the acute treatment of migraine, validating the target for the treatment of migraine. However, for a number of reasons, including issues of liver toxicity with chronic use, the development of CGRP-RAs has yet to produce a viable clinical therapeutic.
Headache is a common complaint for emergency visits. Common drugs used in relief of headache are opioids and their agonists and antagonists, ergot alkaloids, and nonsteroidal anti-nflammatory drugs(NSAIDs). Lack of appropriate medications or serious side effects of available drugs, motivated us to perform the study for evaluating the efficacy of intranasal lidocaine on different types of headache.
Cluster headache is one of the primary headache disorders. It is considered the most severe headache syndrome known to humans. In most instances, this disorder is readily treatable when the correct medications are utilized at the correct dosages. Cluster headache treatment involves abortive, transitional and preventive therapy strategies.
Cluster headache (CH), a primary neurovascular headache syndrome, is characterized by recurrent, unilateral, short-lasting attacks of excruciating pain in the temporal and/or orbital region. The pain is considered one of the most severe pain conditions known to humans. Compared with the general population, first-degree relatives of probands with CH have a significantly increased risk of the same disorder.