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Efficacy - Chronic Migraine

Study Design

The efficacy and safety of Emgality were evaluated in chronic migraine in a Phase 3 trial1,2

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the US and 11 other countries1,2

REGAIN: A 3-month, double-blind, placebo-controlled study that enrolled 1113 adult patients with chronic migraine (defined as ≥15 headache days per month with ≥8 migraine days per month). Participants were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. 240 mg is an unapproved dose. Patients were allowed to use acute headache treatments including migraine-specific medications (ie, triptans, ergotamine derivatives), nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen during the study. A subset of patients (15%) continued 1 concomitant migraine preventive medication. Patients with medication overuse headache were allowed to enroll. Patients were excluded if they had electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event and patients with a history of stroke myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. The primary endpoint was the mean change from baseline in the number of monthly migraine headache days (MHDs) over the 3-month treatment period.<sup>1</sup>

aMSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life. Areas measured included: relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.1,3

See Study Design for EVOLVE-1 and EVOLVE-2

Emgality
Indications and Important Safety Information
Indications

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache

Important Safety Information

CONTRAINDICATIONS
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.


ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.


Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the device.


GZ HCP ISI 10DEC2019

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