Phase 2
Completed N=414
A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache
Migraine Headache
Source: ClinicalTrials.gov NCT02163993 ↗
Enrolled (actual)
414
Serious AEs
0.5%
Results posted
Nov 2018
Primary outcomePrimary: Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase — -3.66; -4.23; -3.92; -4.80 Days
Summary
The main purpose of this study is to evaluate whether the study drug known as galcanezumab is safe and effective in the prevention of migraine headaches.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in the Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase |
-3.66; -4.23; -3.92; -4.80; -4.28 | — |
| SECONDARY Mean Change From Baseline in Number of Migraine Attacks in the Last 28-Day Period of the 12-Week Treatment Phase |
-2.65; -2.98; -2.87; -3.46; -3.01 | — |
| SECONDARY Percentage of Participants With ≥50% Reduction in Number of Migraine Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase |
60.9; 75.4; 65.5; 76.5; 70.1 | — |
| SECONDARY Mean Change From Baseline in the Number of Days of Medication Use for the Treatment of Migraine Headache in the Last 28-Day Period of the 12-Week Treatment Phase |
-2.51; -3.27; -2.58; -3.59; -3.15 | — |
| SECONDARY Mean Change From Baseline in Number of Headache Hours in the Last 28-Day Period of the 12-Week Treatment Phase |
-16.56; -20.15; -19.38; -22.29; -24.45 | — |
| SECONDARY Change From Baseline to 12 Week Endpoint in Migraine Specific Quality of Life (MSQL) Questionnaire Total Scores |
21.08; 27.53; 25.35; 30.23; 27.49 | — |
| SECONDARY Change From Baseline to 12 Week Endpoint in the Headache Impact Test-6™ (HIT-6™) Scores |
-7.26; -9.26; -8.46; -9.95; -8.27 | — |
| SECONDARY Serum Concentration of Galcanezumab |
840; 4650; 13200; 32100 | — |
| SECONDARY Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) |
0.1810; 0.4750; 1.5700; 2.8000; 3.8300 | — |
| SECONDARY Percentage of Participants Developing Anti-drug Antibodies to Galcanezumab |
2.2; 7.7; 4.6; 2.9; 3.1 | — |
| SECONDARY Percentage of Participants With Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Scores |
0; 0; 0; 0; 1.52; 0 | — |
| SECONDARY Mean Change From Baseline in the Number of Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase |
-2.47; -2.81; -2.57; -3.11; -3.37 | — |
| SECONDARY Mean Change From Baseline in the Number of Moderate-Severe Headache Days in the Last 28-Day Period of the 12-Week Treatment Phase |
-2.33; -2.49; -2.33; -2.88; -3.13 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with a history of migraine of at least 1 year prior to enrollment.
- Migraine onset prior to age 50.
Exclusion Criteria
- Current enrollment in, or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device.
- Current use or any prior exposure to any CGRP antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
- History of migraine subtypes including hemiplegic migraine, ophthalmoplegic migraine, and basilar-type migraine.
- Have a history or presence of other medical illness that indicates a medical problem that would preclude study participation.
- Failure to respond to more than two adequately dosed effective migraine prevention treatments.
- Evidence of significant active psychiatric disease, in the opinion of the investigator.
- Women who are pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT02163993). 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.