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

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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

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

Trial documents
2

Trial contacts and locations

95

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Data sourced from clinicaltrials.gov

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