Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial

Cephalalgia : an International Journal of Headache
Vladimir SkljarevskiJyun Yan Yang

Abstract

Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%,  ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire. Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (-2.6, -1.5) and 1.9 (-2.4, -1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection ...Continue Reading

References

May 8, 2002·Cephalalgia : an International Journal of Headache·L H LassenJ Olesen
Jan 31, 2007·Neurology·R B LiptonUNKNOWN AMPP Advisory Group
Feb 27, 2009·JAMA : the Journal of the American Medical Association·Brett D Stauffer
Feb 23, 2010·Lancet Neurology·Peter J Goadsby, Till Sprenger
Feb 4, 2012·Pain Practice : the Official Journal of World Institute of Pain·Ariel BergerGerry Oster
Apr 25, 2012·Neurology·S D SilbersteinUNKNOWN Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society
Aug 21, 2012·Statistics in Medicine·George Kordzakhia, Alex Dmitrienko
Jan 12, 2013·Cephalalgia : an International Journal of Headache·T J SteinerG L Birbeck
May 1, 2015·The Journal of Neuroscience : the Official Journal of the Society for Neuroscience·Rami BursteinDavid Borsook
Sep 18, 2016·Handbook of Clinical Neurology·K R PeckT A Smitherman
Feb 10, 2017·Physiological Reviews·Peter J GoadsbySimon Akerman

❮ Previous
Next ❯

Citations

Nov 15, 2018·Headache·Morris LevinEric Pearlman
Nov 1, 2018·Drugs·Yvette N Lamb
Nov 30, 2018·Expert Opinion on Emerging Drugs·Giorgio LambruPaolo Martelletti
Mar 6, 2019·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·Stewart J Tepper
Mar 15, 2019·Current Treatment Options in Neurology·Sameer Jain, Stephen D Silberstein
Jan 17, 2019·Clinical Pharmacology and Therapeutics·Hsiangkuo YuanStephen D Silberstein
Apr 16, 2019·Headache·Smriti IyengarSheena K Aurora
May 21, 2019·Cephalalgia : an International Journal of Headache·Dustin D RuffSheena K Aurora
Jul 23, 2019·Headache·Jonathan M Borkum
Apr 21, 2019·Journal of Neurology, Neurosurgery, and Psychiatry·Peter J GoadsbySheena K Aurora
Nov 7, 2019·Current Pharmaceutical Design·Cinzia CavestroEugenia Rota
Sep 27, 2019·CNS Drugs·Calvin Chan, Peter J Goadsby
Nov 7, 2019·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·D D RuffP J Goadsby
Oct 9, 2019·European Journal of Neurology : the Official Journal of the European Federation of Neurological Societies·J AilaniS K Aurora
Jul 26, 2019·Neurology. Clinical Practice·Peter J Goadsby
Feb 1, 2020·Expert Opinion on Therapeutic Targets·Anne-Sophie WattiezAndrew F Russo
Mar 3, 2020·Expert Opinion on Drug Safety·Simy K ParikhStephen D Silberstein
Apr 1, 2020·Headache·Christina L SzperkaRobert E Shapiro
Apr 4, 2020·Expert Opinion on Biological Therapy·Calvin Chan, Peter J Goadsby
Mar 27, 2020·Current Opinion in Neurology·Maria Dolores Villar-MartinezPeter J Goadsby
May 22, 2020·Expert Review of Neurotherapeutics·Eleonora De MatteisSimona Sacco
Jun 3, 2020·Expert Review of Pharmacoeconomics & Outcomes Research·Pablo IrimiaCarlos Rubio-Terrés
Jul 9, 2020·Current Pain and Headache Reports·Klaus WernerAndrew D Hershey
Sep 26, 2019·Cephalalgia : an International Journal of Headache·Edita NavratilovaFrank Porreca
Mar 29, 2019·Cephalalgia : an International Journal of Headache·William Kielbasa, Danielle L Helton
Jul 24, 2020·Expert Opinion on Biological Therapy·Luca GianiMassimo Leone
Aug 20, 2020·Expert Opinion on Drug Safety·Eduardo Rivera-MancillaAntoinette MaassenVanDenBrink
Sep 2, 2020·JAMA : the Journal of the American Medical Association

❮ Previous
Next ❯

Clinical Trials Mentioned

NCT02614196

Software Mentioned

EVOLVE
SAS Guide
IWRS

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.