Phase 3
N=520
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Episodic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03963232 ↗Enrolled (actual)
520
Serious AEs
1.6%
Results posted
Aug 2022
Primary outcome: Primary: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase. — -1.99; -3.81 days per month — p=<.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Galcanezumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase. |
-1.99; -3.81 | <.0001 sig |
| SECONDARY Overall Mean Percentage of Participants With ≥30%, ≥50%, ≥75%, 100% Reduction From Baseline in Monthly Migraine Headache Days (MHDs) During the Double-blind Treatment Phase. |
50.3; 73.0; 32.9; 54.9; 12.7; 29.2 | <.0001 sig |
| SECONDARY Overall 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) During the Double-blind Treatment Phase. |
13.94; 21.01 | <.0001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Headache During the Double-blind Treatment Phase. |
-0.71; -2.49 | <.0001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Headache Days During the Double-blind Treatment Phase. |
-2.09; -3.91 | <.0001 sig |
| SECONDARY Percentage of Participants Who Maintain 50% Response Criteria During the Double-blind Treatment Phase. |
12.4; 29.6 | <.0001 sig |
| SECONDARY Overall Mean Change From Baseline in Number of Monthly Migraine Attacks During the Double-blind Treatment Phase. |
-1.57; -2.46 | <.0001 sig |
| SECONDARY Overall Mean Change From Baseline in Number of Monthly Migraine Headache Hours During the Double-blind Treatment Phase. |
-12.83; -31.72 | <.0001 sig |
| SECONDARY Overall Mean Change From Baseline in Number of Monthly Headache Hours During the Double-blind Treatment Phase. |
-12.94; -32.18 | <.0001 sig |
| SECONDARY Overall Mean Change From Baseline in Severity of Migraine Headaches During the Double-blind Treatment Phase. |
-0.03; -0.19 | <.0001 sig |
| SECONDARY Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score at Month 3 During the Double-blind Treatment Phase. |
-0.610; -0.834 | 0.0284 sig |
| SECONDARY Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score at Month 3 During the Double-blind Treatment Phase. |
-10.181; -22.610 | 0.0001 sig |
| SECONDARY Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) During the Double-blind Treatment Phase. |
1.2; 9.3 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab During the Double-blind Treatment Phase. |
14696 | — |
Summary
The reason for this study is to see if the drug galcanezumab is safe and effective in participants with episodic migraine. The study will last about 53 weeks and may include up to 12 visits.
Eligibility Criteria
Inclusion Criteria
- Participants must have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 (1.1 or 1.2) (ICHD-3 2018) with a history of migraine of at least 1 year prior to screening and migraine onset prior to age 50
- Prior to screening, participants must have a history of 4-14 migraine headache days and at least 2 migraine attacks per month on average within the past 3 months
Exclusion Criteria
- Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
- Current use or prior exposure to galcanezumab or another calcitonin gene-related peptide (CGRP) antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody
- Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (for example, adalimumab, infliximab, trastuzumab, bevacizumab, etc.)
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab
- Women who are pregnant or nursing
- History of chronic migraine, daily persistent headache, cluster headache, medication overuse headache, migraine with brainstem aura, or hemiplegic migraine
Data sourced from ClinicalTrials.gov (NCT03963232). 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.