Phase 2
Completed N=459
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
Source: ClinicalTrials.gov NCT02959177 ↗Enrolled (actual)
459
Serious AEs
0.8%
Results posted
Feb 2020
Primary outcomePrimary: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) — -3.60; -3.36; -0.59 Days — p=<0.001
Summary
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) |
-3.60; -3.36; -0.59 | <0.001 sig |
| SECONDARY Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days |
49.8; 48.2; 20.3 | — |
| SECONDARY Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days |
25.5; 25.0; 9.6 | — |
| SECONDARY Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days |
9.0; 8.1; 2.8 | — |
| SECONDARY Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire |
17.13; 15.91; 10.12 | <0.001 sig |
| SECONDARY Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use |
-3.02; -2.81; -0.12 | <0.001 sig |
| SECONDARY Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score |
-0.25; -0.41; -0.15 | — |
| SECONDARY Overall Mean Change From Baseline in Headache Hours |
-14.56; -16.46; -2.73 | <0.001 sig |
| SECONDARY Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score |
-7.06; -5.13; -2.16 | <0.001 sig |
| SECONDARY Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) |
35.58; 44.14; 7.56; 26.92; 23.42; 27.11 | — |
| SECONDARY Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab |
9.57; 10.53; 1.30 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
20400; 40600 | — |
| SECONDARY Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) |
4.35; 5.40; 0.634 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of 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, and migraine onset prior to age 50.
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 other antibodies to CGRP or its receptor.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
- 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 (NCT02959177). 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.