Episodic Cluster HeadachePhase 3NCT02797951
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
A Phase 3 study testing Galcanezumab in people with Episodic Cluster Headache and Chronic Cluster Headache, run by Eli Lilly and Company at 40 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Episodic Cluster Headache, Chronic Cluster Headache
- What is being tested?
- Galcanezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 40 sitesin 12 countries
- Study dates
- 13 Jul 2016to 21 Jan 2021
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
40 sites in 12 countries.
40 sites in 12 countries
United States11 sites
Michigan Head, Pain and Neurological Institute
Ann Arbor, Michigan, 48104
Atlanta Center of Medical Research
Atlanta, Georgia, 30331
Northwest Clinical Research Center
Bellevue, Washington, 98007-4209
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Colorado Neurological Institute
Englewood, Colorado, 80113
Stanford University Hospital
Palo Alto, California, 94304
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Mayo Clinic Hospital
Phoenix, Arizona, 85054
California Medical Clinic for Headache
Santa Monica, California, 90404
New England Institute for Clinical Research
Stamford, Connecticut, 06905
University of South Florida
Tampa, Florida, 33612
France5 sites
CHRU de Lille - Hôpital Roger Salengro
Lille, Cedex, 59037
APHM Hôpital de la Timone
Marseille, 13385
Hôpital de Cimiez
Nice, 06000
Hopital Lariboisière
Paris, 75475
CHU St Etienne Hopital Nord
Saint-Etienne, 42000
Germany5 sites
Praxis Dr. Philipp Stude
Bochum, North Rhine-Westphalia, 44787
Universitaetsklinikum Essen
Essen, 45147
Universitätsklinikum Jena
Jena, Thuringia, 07747
Migräne- und Kopfschmerzklinik GmbH & Co. KG
Königstein im Taunus, Hesse, 61462
Klinikum der Universität München
München, Bavaria, 81377
Italy3 sites
Azienda Ospedaliera Universitaria Careggi
Florence, 50139
Istituto Neurologico Carlo Besta
Milan, 20133
Fondazione Istituto Neurologico Nationale C. Mondino
Pavia, 27100
United Kingdom3 sites
Hull Royal Infirmary
Hull, East Yorkshire, HU3 2JZ
Walton Centre for Neurology and Neurosurgery
Liverpool, Lancashire, L9 7LJ
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
Belgium2 sites
Universitair Ziekenhuis Gent
Ghent, B-9000
Centre Hospitalier Regional de la Citadelle
Liège, 4000
Canada2 sites
Centre de Traitement Neurologique
Montreal, H2W 1V1
Stroyan Research
Toronto, Ontario, M4S 1Y2
Finland2 sites
Suomen Terveystalo
Jyväskylä, 40100
Terveystalo Pulssi
Turku, 20100
Greece2 sites
401 Army General Hospital of Athens
Athens, Attica, 11525
Eginition Hospital of Athens
Athens, 11528
Netherlands2 sites
Boerhaave Medisch Centrum
Amsterdam, 1078 VV
Canisius-Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ
Spain2 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Clínico Universitario de Valencia
Valencia, 46010
About this study
Official title: A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache
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).
- Being tested
- Galcanezumab
- Keywords
- cluster headache, headache, brain diseases, central nervous system diseases, headache disorders, headache disorders, primary, nervous system diseases, neurologic manifestations, pain, trigeminal autonomic cephalalgias
- Medical subject headings
- Cluster Headache, Headache, Brain Diseases, Central Nervous System Diseases, Headache Disorders, Headache Disorders, Primary, Nervous System Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GalcanezumabDrug
Also called LY2951742
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Galcanezumab | Experimental | Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month. Receives: Drug: Galcanezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
A TEAE is defined as the reported AEs that first occurred or worsened during the post-baseline phase compared with the baseline phase.
An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. A summary of serious and other non-serious adverse events regardless of causality is located in the reported adverse events module.
Measured: Baseline through End of Study (Up to 4 Years)
Number of Participants With Suicidal Ideation and Behaviours Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).
- Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: Wish to be Dead, Non-specific Active Suicidal Thoughts, Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act, Active Suicidal Ideation with Some Intent to Act, without Specific Plan, Active Suicidal Ideation with Specific Plan and Intent.
- Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: Preparatory Acts or Behaviour, Aborted Attempt, Interrupted Attempt, Actual Attempt (non-fatal), Completed Suicide.
Measured: Baseline through End of Study (Up to 4 Years)
Secondary outcomes (1)
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab
A participant is considered TE-ADA positive if:
- ADA "not present" baseline result and any subsequent "present" postbaseline ADA result with a titer of at least 1:20 (treatment-induced), or
- ADA "present" baseline result and any subsequent "present" postbaseline ADA result with a 4-fold or greater increase in titer from baseline (treatment-boosted).
Measured: Baseline through End of Study (Up to 4 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start13 Jul 2016
- Primary completion21 Jan 2021
- Study completion21 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Episodic Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02797951
- Sponsor's protocol ID
- 16351
- Other IDs
- I5Q-MC-CGAR, 2015-005234-21, 2015
- Status last verified
- Jan 2022
- First submitted
- 9 Jun 2016
- Last updated
- 10 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Riesenberg R, Gaul C, Stroud CE, Dong Y, Bangs ME, Wenzel R, Martinez JM, Oakes TM. Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache. Cephalalgia. 2022 Oct;42(11-12):1225-1235. doi: 10.1177/03331024221103509. Epub 2022 May 27.
PubMed 35633025