A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine (CONQUER)

Lilly

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03559257

I5Q-MC-CGAW (Other Identifier)

16670

2018-000600-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.

Enrollment: 463 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of migraine or chronic migraine.
• History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.
• History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.
• Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.

Exclusion criteria

• Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
• Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody.
• History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine).
• Pregnant or nursing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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463 participants in 2 patient groups, including a placebo group

Galcanezumab

Experimental group

Description:

Galcanezumab administered subcutaneously (SC).

Treatment:

Drug: Galcanezumab

Placebo

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo