A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients With Episodic Migraine - the EVOLVE-1 Study
Overview
- Phase
- Phase 3
- Intervention
- Galcanezumab
- Conditions
- Migraine
- Sponsor
- Eli Lilly and Company
- Enrollment
- 862
- Locations
- 84
- Primary Endpoint
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with episodic migraine.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Galcanezumab 120mg
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.
Intervention: Galcanezumab
Galcanezumab 240mg
Galcanezumab 240mg given by SC injection once a month for 6 months.
Intervention: Galcanezumab
Placebo
Placebo given by SC injection once a month for 6 months.
Intervention: Placebo
Outcomes
Primary Outcomes
Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days
Time Frame: Baseline, Month 1 through Month 6
Migraine Headache Day (MHD):A calendar day on which a migraine headache or probable migraine headache occurred. Migraine Headache : A headache, with or without aura, of ≥30 minutes duration with both of the following required features (A and B): A) At least 2 of the following headache characteristics: Unilateral location; Pulsatile quality; Moderate or severe pain intensity; Aggravation by or causing avoidance of routine physical activity; AND B) During headache at least one of the following: Nausea and/or vomiting; Photophobia and phonophobia; Overall mean is derived from the average of months 1 to 6 from mixed model repeated measures (MMRM) model. Least Square (LS) mean was calculated using mixed model repeated measures (MMRM) model with treatment, pooled country, month, and treatment by month, baseline, and baseline by month as fixed effects.
Secondary Outcomes
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Month 6)
- Overall Mean Change From Baseline in Headache Hours(Baseline, Month 1 through Month 6)
- Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score(Baseline, Month 6)
- Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 (v2.1) Role Function Restrictive Domain(Baseline, Month 4 through Month 6)
- Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab(Month 1 through Month 6)
- Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days(Baseline, Month 1 through Month 6)
- Pharmacokinetics (PK): Serum Concentrations of Galcanezumab(Month 6)
- Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache(Baseline, Month 1 through Month 6)
- Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Rating(Baseline, Month 4 through Month 6)