Phase 3
N=240
A Study of Galcanezumab in Participants With Chronic Cluster Headache
Chronic Cluster Headache
Bottom Line
View on ClinicalTrials.gov: NCT02438826 ↗Enrolled (actual)
240
Serious AEs
4.7%
Results posted
Jun 2019
Primary outcome: Primary: Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency — -4.59; -5.38 cluster headache attacks per week — p=0.334
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Galcanezumab 300 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency |
-4.59; -5.38 | 0.334 |
| SECONDARY Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks |
27.1; 32.6 | 0.170 |
| SECONDARY Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks |
17.50; 16.24 | 0.946 |
| SECONDARY Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks |
39.0; 49.1 | 0.057 |
| SECONDARY Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) |
35.6; 30.4 | 0.437 |
| SECONDARY Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) |
35.6; 30.4 | 0.437 |
| SECONDARY Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I) |
35.6; 30.4 | 0.437 |
| SECONDARY Percentage of Participants With Suicidal Ideation Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) |
5.04; 4.31 | — |
| SECONDARY Percentage of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS) |
0; 0 | — |
| SECONDARY Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab (LY2951742) |
0; 0.88 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
31,100 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
31,100 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
31,100 | — |
| SECONDARY Pharmacokinetics (PK): Serum Concentration of Galcanezumab |
31,100 | — |
Summary
The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.
Eligibility Criteria
Inclusion Criteria
- Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting <1 month, for at least 1 year.
- 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 (NCT02438826). 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.