Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study

Lilly

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Galcanezumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02614183

15767

I5Q-MC-CGAG (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine.

Enrollment: 862 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a diagnosis of episodic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, migraine onset prior to age 50 and MONTHLY frequency of 4-14 Migraine Headache Days (MHD).

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 CGRP antibody.
• Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab.
• 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) defined by IHS ICHD-3 beta.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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862 participants in 3 patient groups, including a placebo group

Galcanezumab 120mg

Experimental group

Description:

Galcanezumab given by subcutaneous (SC) injection at 120mg dose once a month for 6 months. Participants received a loading dose of 240mg (2 injections of 120mg each) was administered at visit 3 only.

Treatment:

Drug: Galcanezumab

Galcanezumab 240mg

Experimental group

Description:

Galcanezumab 240mg given by SC injection once a month for 6 months.

Treatment:

Drug: Galcanezumab

Placebo

Placebo Comparator group

Description:

Placebo given by SC injection once a month for 6 months.

Treatment:

Drug: Placebo