Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
Status and phase
Completed
Phase 3
Conditions
Migraine
Treatments
Drug: Galcanezumab
Drug: Placebo
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic migraine.
Enrollment
986 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta version (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 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 Calcitonin Gene-Related Peptide (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
986 participants in 6 patient groups, including a placebo group
Galcanezumab 120mg
Experimental group
Description:
Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.
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
Galcanezumab 120mg Maximum Extended Enrollment Cohort
Experimental group
Description:
Galcanezumab 240mg given as loading dose at first dosing visit followed by galcanezumab 120mg once a month for 5 months by subcutaneous (SC) injection.
Treatment:
Drug: Galcanezumab
Galcanezumab 240mg Maximum Extended Enrollment Cohort
Experimental group
Description:
Galcanezumab 240mg given by SC injection once a month for 6 months.
Treatment:
Drug: Galcanezumab
Placebo Maximum Extended Enrollment Cohort
Placebo Comparator group
Description:
Placebo given by SC injection once a month for 6 months.
Treatment:
Drug: Placebo
Trial contacts and locations
113
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Data sourced from clinicaltrials.gov
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