Phase 3
N=1,117
Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02614261 ↗Enrolled (actual)
1,117
Serious AEs
1.8%
Results posted
Jan 2019
Primary outcome: Primary: Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) — -2.74; -4.83; -4.62 Migraine Headache Days per Month — p=<.001
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
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD) |
-2.74; -4.83; -4.62 | <.001 sig |
| SECONDARY Number of Participants With Reduction From Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days |
123; 90; 97; 44; 34; 40 | .004 sig |
| SECONDARY Mean Change From Baseline in the Migraine-Specific Quality of Life Questionnaire (MSQ) Role-function Restrictive Domain |
16.76; 21.81; 23.05 | <.001 sig |
| SECONDARY Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache |
-2.23; -4.74; -4.25 | <.001 sig |
| SECONDARY Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score |
-0.62; -0.76; -0.91 | .181 |
| SECONDARY Overall Mean Change From Baseline in Headache Hours |
-13.44; -36.15; -31.53 | <.001 sig |
| SECONDARY Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score |
-11.53; -20.27; -17.02 | .025 sig |
| SECONDARY Percentage of Participants Developing Treatment Emergent Anti-drug Antibodies (ADA) to Galcanezumab |
8; 7; 7 | .263 |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab |
— | — |
| SECONDARY Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) |
0.529; 4.02; 4.85 | — |
| SECONDARY Serum Concentrations of Galcanezumab |
16900; 29000 | — |
Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.
Eligibility Criteria
Inclusion Criteria
Main Study:
- Have a diagnosis of chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (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.
Israel addendum:
- Participants must have completed all phases of main study, including the 4-month post-treatment follow-up phase, during which no investigational product was administered.
- Participants also must be considered by the investigator to have benefited from galcanezumab treatment and must have exhausted alternative therapies for the prevention of migraine.
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 calcitonin gene-related peptide (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 (NCT02614261). 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.