Efficacy - Episodic Cluster Headache

Study Design

The efficacy and safety of Emgality 300 mg were established in an episodic cluster headache study¹

Emgality 300 mg was studied in a randomized, 8-week, double-blind, placebo-controlled study in adult patients¹

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