Phase 3
Completed N=270
A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura
Source: ClinicalTrials.gov NCT02614287 ↗Enrolled (actual)
270
Serious AEs
3.0%
Results posted
Jan 2019
Primary outcomePrimary: Percentage of Participants Who Discontinued Due to Adverse Event — 4.65; 4.96 Percentage of Participants — p=1
◆ Published Evidence
Highly cited
141citations · ~18 / year
A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine.
Summary
The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.
Linked Publications (4)
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A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine.
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Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies.
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Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine.
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Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Discontinued Due to Adverse Event |
4.65; 4.96 | 1 |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab |
— | — |
| SECONDARY Serum Concentrations of Galcanezumab |
16500; 31600 | — |
| SECONDARY Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) |
2.74; 3.85 | — |
| SECONDARY Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab |
12.40; 7.30 | .215 |
| SECONDARY Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD) |
-5.61; -6.47 | 0.60 |
| SECONDARY Overall Mean Change From Baseline in the Number of Headache Days |
-2.17; -2.09 | .835 |
| SECONDARY Percentage of Participants With Overall Reduction From Baseline ≥50% in Monthly Migraine Headache Days |
65.6; 73.7 | .063 |
| SECONDARY Overall Mean Change From Baseline in the Frequency of Medication Use for the Acute Treatment of Migraines or Headaches |
-5.09; -5.05 | .937 |
| SECONDARY Overall Mean Patient Global Impression-Improvement (PGI-I) Score |
2.18; 1.99 | 0.073 |
| SECONDARY Overall Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score |
-33.58; -32.67 | .747 |
| SECONDARY Overall Mean Change From Baseline on the Migraine-Specific Quality of Life Questionnaire (MSQ) Version 2.1 |
28.27; 30.25; 31.55; 33.40; 22.08; 23.33 | 0.203 |
| SECONDARY Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M) |
57.78; 58.04; 18.89; 15.18; 66.67; 63.39 | — |
| SECONDARY Number of Participant Visits With Positive Reponses by Device Type Subcutaneous Administration Assessment Questionnaire Q1, Q3-Q12 |
611; 688; 589; 660; 580; 659 | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
- Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.
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 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 (NCT02614287) 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.