Phase 3
N=165
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Episodic Cluster Headache · Chronic Cluster Headache
Bottom Line
View on ClinicalTrials.gov: NCT02797951 ↗Enrolled (actual)
165
Serious AEs
10.4%
Results posted
Feb 2022
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) — 119; 17 Participants
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
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs) |
119; 17 | — |
| PRIMARY Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) |
2; 0 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab |
8 | — |
Summary
The main purpose of this study is to assess the long-term safety and tolerability of galcanezumab administered up to once monthly in participants with episodic or chronic cluster headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM (NCT02438826).
Eligibility Criteria
Inclusion Criteria
- Participants who participated in and completed either study CGAL or study CGAM.
- Investigator judges the participant as reliable to follow all study procedures, keep all study visits, and be compliant with study requirements.
Exclusion Criteria
- Current enrollment in or discontinuation within the last 30 days from, a clinical trial involving any investigational drug or device (with the exception of Study CGAL or Study CGAM).
- 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) (with the exception of Study CGAL or Study CGAM).
- 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 (NCT02797951). 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.