Efficacy - Episodic Cluster Headache


Study Design

The efficacy and safety of Emgality were established in an episodic cluster headache study1

Emgality was studied in a randomized, 8-week, double-blind, placebo-controlled study in adult patients1

An 8-week, randomized, double-blind, placebo-controlled study that enrolled 106 adults with episodic cluster headache who had a maximum of 8 attacks per day, a minimum of 1 attack every other day, and at least 4 attacks during the prospective 7-day baseline period. Patients were randomized to once-monthly Emgality 300 mg or placebo. Patients were allowed to use certain specified acute/abortive cluster headache treatments, including triptans, oxygen, acetaminophen, and nonsteroidal anti-inflammatory drugs during the study. The study excluded patients on other treatments intended to reduce the frequency of cluster headache attacks; patients with medication overuse headache; patients with electrocardiogram abnormalities compatible with an acute cardiovascular event or conduction delay; and patients with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. In addition, patients with any history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, or vasospastic angina; clinical evidence of peripheral vascular disease; or diagnosis of Raynaud’s disease were excluded. The primary efficacy endpoint was the mean change from baseline in weekly cluster headache attack frequency over Weeks 1 to 3. A secondary endpoint was the percentage of patients who achieved a response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3.<sup>1</sup>

Key inclusion criteria1

  • Adults who met International Classification of Headache Disorders, 3rd edition (beta version) (ICHD-3-beta) diagnostic criteria for episodic cluster headache and had a maximum of 8 attacks per day, a minimum of 1 attack every other day, and at least 4 attacks during the prospective 7-day baseline period
  • Certain specified acute/abortive cluster headache treatments were allowed, including triptans, oxygen, acetaminophen, and nonsteroidal anti-inflammatory drugs (NSAIDs)

Key exclusion criteria1

  • The study excluded patients on other treatments intended to reduce the frequency of cluster headache attacks; patients with medication overuse headache; patients with electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event or conduction delay; and patients with a history of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. In addition, patients with any history of stroke, intracranial or carotid aneurysm, intracranial hemorrhage, or vasospastic angina; clinical evidence of peripheral vascular disease; or diagnosis of Raynaud’s disease were excluded

Study endpoints1

Primary

  • Mean change from baseline in weekly cluster headache attack frequency over Weeks 1 to 3

Secondary

  • Percentage of patients who achieved a response (defined as a reduction from baseline of 50% or greater in weekly cluster headache attack frequency) at Week 3
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 anaphylaxis, angioedema, dyspnea, urticaria, and rash, have been reported with Emgality. 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 04JUN2019