Phase 3 N=270 Randomized Treatment

A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT02614287 ↗

Enrolled (actual)

270

Serious AEs

3.0%

Results posted

Jan 2019

Primary outcome: Primary: Percentage of Participants Who Discontinued Due to Adverse Event — 4.65; 4.96 Percentage of Participants — p=1

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Galcanezumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: May 2017

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	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02614287). 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.