Phase 3
Completed N=986
Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study
Source: ClinicalTrials.gov NCT02614196 ↗Enrolled (actual)
986
Serious AEs
1.5%
Results posted
Jan 2019
Primary outcomePrimary: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days — -2.28; -4.29; -4.18 Migraine Headache Days per Month — p=<.001
◆ Published Evidence
Established
43citations · ~9 / year
Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine.
Summary
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.
Linked Publications (5)
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Effect of galcanezumab on severity and symptoms of migraine in phase 3 trials in patients with episodic or chronic migraine.
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Shift from high-frequency to low-frequency episodic migraine in patients treated with Galcanezumab: results from two global randomized clinical trials.
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Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials.
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Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis.
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Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days |
-2.28; -4.29; -4.18 | <.001 sig |
| SECONDARY Mean Percentage of Participants With Reduction From Baseline ≥50%, ≥75%, and 100% in Monthly Migraine Headache Days |
36; 59.3; 56.5; 17.8; 33.5; 34.3 | — |
| SECONDARY Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 Role Function Restrictive Domain |
19.65; 28.47; 27.04 | <.001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache |
-1.85; -3.67; -3.63 | <.001 sig |
| SECONDARY Mean Change From Baseline in Patient Global Impression of Severity (PGI-S) Rating |
-0.94; -1.22; -1.17 | .002 sig |
| SECONDARY Overall Mean Change From Baseline in Headache Hours |
-10.89; -26.07; -24.44 | <.001 sig |
| SECONDARY Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score |
-12.02; -21.17; -20.24 | <.001 sig |
| SECONDARY Percentage of Participants Developing Anti-drug Antibodies (ADA) to Galcanezumab |
0.45; 8.56; 5.14 | <.001 sig |
| SECONDARY Pharmacokinetics (PK): Serum Concentrations of Galcanezumab |
17400; 32200 | — |
| SECONDARY Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) |
0.541; 3.93; 4.98 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02614196) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.