Chronic Cluster Headache Clinical Trial
Official title:
A Phase 3b Multicenter, Single-Arm, Open-Label Safety Study of LY2951742 (Galcanezumab) in Patients With Episodic or Chronic Cluster Headache
Verified date | January 2022 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 165 |
Est. completion date | January 21, 2021 |
Est. primary completion date | January 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Gent | Gent | |
Belgium | Centre Hospitalier Regional de la Citadelle | Liege | |
Canada | Centre de Traitement Neurologique | Montreal | |
Canada | Stroyan Research | Toronto | Ontario |
Denmark | Glostrup Hospital | Glostrup | |
Finland | Suomen Terveystalo | Jyväskylä | |
Finland | Terveystalo Pulssi | Turku | |
France | CHRU de Lille - Hôpital Roger Salengro | Lille | Cedex |
France | APHM Hôpital de la Timone | Marseille Cedex 5 | |
France | Hôpital de Cimiez | Nice | |
France | Hopital Lariboisière | Paris | |
France | CHU St Etienne Hopital Nord | Saint Etienne Cedex 2 | |
Germany | Praxis Dr. Philipp Stude | Bochum | Nordrhein-Westfalen |
Germany | Universitaetsklinikum Essen | Essen | |
Germany | Universitätsklinikum Jena | Jena | Thüringen |
Germany | Migräne- und Kopfschmerzklinik GmbH & Co. KG | Königstein | Hessen |
Germany | Klinikum der Universität München | München | Bayern |
Greece | 401 Army General Hospital of Athens | Athens | Attica |
Greece | Eginition Hospital of Athens | Athens | |
Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
Italy | Istituto Neurologico Carlo Besta | Milano | |
Italy | Fondazione Istituto Neurologico Nationale C. Mondino | Pavia | |
Netherlands | Boerhaave Medisch Centrum | Amsterdam | |
Netherlands | Canisius-Wilhelmina Ziekenhuis | Nijmegen | |
Spain | Hospital Universitari Vall d'Hebron | Barcelona | |
Spain | Hospital Clínico Universitario de Valencia | Valencia | |
United Kingdom | Hull Royal Infirmary | Hull | East Yorkshire |
United Kingdom | Walton Centre for Neurology and Neurosurgery | Liverpool | Lancashire |
United Kingdom | Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire |
United States | Michigan Head, Pain and Neurological Institute | Ann Arbor | Michigan |
United States | Atlanta Center of Medical Research | Atlanta | Georgia |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Clinical Trials of South Carolina | Charleston | South Carolina |
United States | Colorado Neurological Institute | Englewood | Colorado |
United States | Stanford University Hospital | Palo Alto | California |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Mayo Clinic Hospital | Phoenix | Arizona |
United States | California Medical Clinic for Headache | Santa Monica | California |
United States | New England Institute for Clinical Research | Stamford | Connecticut |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
United States, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baseline through End of Study (Up to 4 Years) | |
Primary | 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. |
Baseline through End of Study (Up to 4 Years) | |
Secondary | 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). |
Baseline through End of Study (Up to 4 Years) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02462395 -
Anodal Transcranial Direct Stimulation (tDCS) for the Treatment of Chronic Cluster Headache
|
Phase 2/Phase 3 | |
Completed |
NCT05064397 -
A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)
|
Phase 3 | |
Recruiting |
NCT01701245 -
Prevention and Acute Treatment of Chronic Cluster Headache Compared to Standard of Care
|
Phase 2 | |
Completed |
NCT01151631 -
Occipital Nerve Stimulation in Medically Intractable Chronic Cluster Headache
|
Phase 3 | |
Recruiting |
NCT06124534 -
Bilateral Occipital Nerve Field Stimulation for the Treatment of dtCCH
|
N/A | |
Unknown status |
NCT00399243 -
Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache
|
Phase 4 | |
Recruiting |
NCT05868044 -
REsponse to Combined SONS and ONS in Chronic Cluster headachE
|
N/A | |
Completed |
NCT01616511 -
Pathway CH-1 Long-Term Follow-Up
|
N/A | |
Completed |
NCT01359631 -
Cephalic Vascular Recording Upon SPG Stimulation
|
N/A | |
Completed |
NCT02438826 -
A Study of Galcanezumab in Participants With Chronic Cluster Headache
|
Phase 3 | |
Completed |
NCT02510729 -
SPG Neurostimulation in Cluster Patients
|
N/A | |
Active, not recruiting |
NCT02168764 -
Sphenopalatine Ganglion Stimulation for the Treatment of Chronic Cluster Headache
|
N/A | |
Not yet recruiting |
NCT05477459 -
LSD to Improve Cluster Headache Impact Trial
|
Phase 2 | |
Completed |
NCT03244735 -
Efficacy of Modified Atkins Ketogenic Diet in Chronic Cluster Headache: a Prospective Case Series
|
N/A | |
Terminated |
NCT02964338 -
A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH)
|
Phase 3 | |
Completed |
NCT01255813 -
Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
|
N/A | |
Active, not recruiting |
NCT05023460 -
Treatment of Chronic Cluster Headache With TENS and ONS
|
N/A |