A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache

Completed · Phase 3

Conditions studied: Episodic Cluster Headache, Chronic Cluster Headache

In brief

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).

Key facts

Study ID

NCT02797951

Run by

Eli Lilly and Company

People needed

165

Starts

2016-07-13

Expected to finish

2021-01-21

Last updated by the study team

2022-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Stanford University Hospital — Palo Alto, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• Colorado Neurological Institute — Englewood, Colorado, United States
• New England Institute for Clinical Research — Stamford, Connecticut, United States
• University of South Florida — Tampa, Florida, United States
• Atlanta Center of Medical Research — Atlanta, Georgia, United States
• Michigan Head, Pain and Neurological Institute — Ann Arbor, Michigan, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Clinical Trials of South Carolina — Charleston, South Carolina, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Centre Hospitalier Regional de la Citadelle — Liège, Belgium
• Stroyan Research — Toronto, Ontario, Canada
• Centre de Traitement Neurologique — Montreal, Canada
• Glostrup Hospital — Glostrup Municipality, Denmark
• Suomen Terveystalo — Jyväskylä, Finland
• Terveystalo Pulssi — Turku, Finland
• CHRU de Lille - Hôpital Roger Salengro — Lille, Cedex, France
• APHM Hôpital de la Timone — Marseille, France
• Hôpital de Cimiez — Nice, France
• Hopital Lariboisière — Paris, France
• CHU St Etienne Hopital Nord — Saint-Etienne, France
• Klinikum der Universität München — München, Bavaria, Germany
• Migräne- und Kopfschmerzklinik GmbH & Co. KG — Königstein im Taunus, Hesse, Germany

Full record on ClinicalTrials.gov

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