Phase 3
Completed N=1,117
Evaluation of Galcanezumab in the Prevention of Chronic Migraine
Source: ClinicalTrials.gov NCT02614261 ↗Enrolled (actual)
1,117
Serious AEs
1.8%
Results posted
Jan 2019
Primary outcomePrimary: 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
◆ Published Evidence
Established
42citations · ~11 / year
Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study.
Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.
Linked Publications (5)
-
Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study.
-
Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials.
-
Galcanezumab Provides Consistent Efficacy Throughout the Dosing Interval Among Patients with Episodic and Chronic Migraine: A Post Hoc Analysis.
-
Benefit-Risk Assessment of Galcanezumab Versus Placebo for the Treatment of Episodic and Chronic Migraine Using the Metrics of Number Needed to Treat and Number Needed to Harm.
-
Shift from chronic to episodic migraine frequency in a long-term phase 3 study of galcanezumab.
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 | — |
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) 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.