Phase 3
Completed N=463
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
Source: ClinicalTrials.gov NCT03559257 ↗Enrolled (actual)
463
Serious AEs
1.4%
Results posted
Jul 2020
Primary outcomePrimary: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days — -1.02; -4.14 Days — p=<0.0001
◆ Published Evidence
Emerging
14citations · ~5 / year
Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine.
Summary
The purpose of this study is to assess the safety and efficacy of galcanezumab in people with treatment-resistant episodic or chronic migraine.
Linked Publications (5)
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Validation and meaningful within-patient change in work productivity and activity impairment questionnaire (WPAI) for episodic or chronic migraine.
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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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Efficacy of galcanezumab in patients with migraine and history of failure to 3-4 preventive medication categories: subgroup analysis from CONQUER study.
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Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER).
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Effect of Galcanezumab on Total Pain Burden in Patients Who Had Previously Not Benefited from Migraine Preventive Medication (CONQUER Trial): A Post Hoc Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days |
-1.02; -4.14 | <0.0001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days in Participants With Episodic Migraine |
-0.31; -2.88 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in Monthly Migraine Headache Days |
13.3; 37.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With Episodic Migraine With ≥50% Reduction From Baseline in Monthly Migraine Headache Days |
17.1; 41.8 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) |
10.68; 23.21 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Role Function-Restrictive Domain Score of the Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQ v2.1) in Participants With Episodic Migraine |
11.88; 23.39 | <0.0001 sig |
| SECONDARY Percentage of Participants With Episodic Migraine With ≥75% Reduction From Baseline in Monthly Migraine Headache Days |
3.7; 18.4 | 0.0001 sig |
| SECONDARY Percentage of Participants With Episodic Migraine With 100% Reduction From Baseline in Monthly Migraine Headache Days |
0.00; 7.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥75% Reduction From Baseline in Monthly Migraine Headache Days |
3.3; 14.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With 100% Reduction From Baseline in Monthly Migraine Headache Days |
0.000; 4.9 | <0.0001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Days With Acute Headache Medication Use |
-0.80; -4.19 | <0.0001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Headache Days |
-1.05; -4.18 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Migraine Disability Assessment Test (MIDAS) Total Score |
-3.295; -21.097 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the 4-item Migraine Interictal Burden Scale (MIBS-4) |
-0.78; -1.83 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Work Productivity and Activity Impairment Questionnaire (WPAI) |
-8.644; -20.713; -2.900; -4.224; -2.564; -12.504 | <0.0001 sig |
| SECONDARY Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) |
-0.283; -0.664 | 0.0003 sig |
| SECONDARY Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (US) |
-0.002; 0.013 | 0.1267 |
| SECONDARY Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - Health State Index (UK) |
-0.001; 0.017 | 0.1630 |
| SECONDARY Mean Change From Baseline in the European Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) - VAS Score |
-0.086; 3.376 | 0.0277 sig |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of migraine or chronic migraine.
- History of migraine headaches at least 1 year prior to screening, with onset prior to age 50.
- History of at least 4 migraine headache days and at, with at least 1 headache-free day per month on average within the past 3 months.
- Have documentation of 2 to 4 migraine preventive medication category failures due to inadequate efficacy or tolerability, in the past 10 years.
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.
- 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).
- Pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT03559257) 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.