Phase 3
N=109
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
Episodic Cluster Headache
Bottom Line
View on ClinicalTrials.gov: NCT02397473 ↗Enrolled (actual)
109
Serious AEs
1.0%
Results posted
Mar 2019
Primary outcome: Primary: Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks — -5.22; -8.69 Cluster Headache Attacks per Week — p=0.036
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
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks |
-9.97; -10.80 | 0.493 |
| SECONDARY Percentage of Participants With 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks |
52.63; 71.43 | 0.046 sig |
| SECONDARY Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks |
-9.97; -10.80 | 0.493 |
| SECONDARY Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) |
66.1; 71.9 | 0.575 |
| SECONDARY Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) |
66.1; 71.9 | 0.575 |
| SECONDARY Percentage of Participants With 50% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks |
70.4; 69.6 | 0.910 |
| SECONDARY Percentage of Participants With 30% or Greater Reduction From Baseline in Number of Weekly Cluster Headache Attacks |
78.9; 77.7 | 0.841 |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
26400 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
26400 | — |
| SECONDARY Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab |
0; 0 | — |
| SECONDARY Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
| SECONDARY Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1 month.
- Participants are able to distinguish cluster headache attacks from other headaches.
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 calcitonin-gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).
- Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
- A history of migraine variants that could implicate or could be confused with ischemia.
- Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins.
- A history or presence of other medical illness that indicates a medical problem that would preclude study participation.
- Evidence of significant active or unstable psychiatric disease, in the opinion of the investigator.
- Women who are pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT02397473). 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.