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| ID | Type | Description | Link |
|---|---|---|---|
| I5Q-MC-CGAR | Other Identifier | Eli Lilly and Company | |
| 2015-005234-21 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galcanezumab | Experimental | Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galcanezumab | Drug | Administered SC |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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).
| Baseline through End of Study (Up to 4 Years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA) to Galcanezumab | A participant is considered TE-ADA positive if:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | United States | ||
| Stanford University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35633025 | Derived | 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. |
| Label | URL |
|---|---|
| A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache | View source |
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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.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Participants who completed one of the parent studies I5Q-MC-CGAL (NCT02397473) or I5Q-MC-CGAM (NCT02438826) were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Galcanezumab 300 mg SC | Participants received 300 milligram (mg) Galcanezumab administered subcutaneously (SC) up to once a month. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2017 | Aug 4, 2021 |
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| Baseline through End of Study (Up to 4 Years) |
| Palo Alto |
| California |
| 94304 |
| United States |
| California Medical Clinic for Headache | Santa Monica | California | 90404 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Atlanta Center of Medical Research | Atlanta | Georgia | 30331 | United States |
| Michigan Head, Pain and Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Trials of South Carolina | Charleston | South Carolina | 29406 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007-4209 | United States |
| Universitair Ziekenhuis Gent | Ghent | B-9000 | Belgium |
| Centre Hospitalier Regional de la Citadelle | Liège | 4000 | Belgium |
| Stroyan Research | Toronto | Ontario | M4S 1Y2 | Canada |
| Centre de Traitement Neurologique | Montreal | H2W 1V1 | Canada |
| Glostrup Hospital | Glostrup Municipality | 2600 | Denmark |
| Suomen Terveystalo | Jyväskylä | 40100 | Finland |
| Terveystalo Pulssi | Turku | 20100 | Finland |
| CHRU de Lille - Hôpital Roger Salengro | Lille | Cedex | 59037 | France |
| APHM Hôpital de la Timone | Marseille | 13385 | France |
| Hôpital de Cimiez | Nice | 06000 | France |
| Hopital Lariboisière | Paris | 75475 | France |
| CHU St Etienne Hopital Nord | Saint-Etienne | 42000 | France |
| Klinikum der Universität München | München | Bavaria | 81377 | Germany |
| Migräne- und Kopfschmerzklinik GmbH & Co. KG | Königstein im Taunus | Hesse | 61462 | Germany |
| Praxis Dr. Philipp Stude | Bochum | North Rhine-Westphalia | 44787 | Germany |
| Universitätsklinikum Jena | Jena | Thuringia | 07747 | Germany |
| Universitaetsklinikum Essen | Essen | 45147 | Germany |
| 401 Army General Hospital of Athens | Athens | Attica | 11525 | Greece |
| Eginition Hospital of Athens | Athens | 11528 | Greece |
| Azienda Ospedaliera Universitaria Careggi | Florence | 50139 | Italy |
| Istituto Neurologico Carlo Besta | Milan | 20133 | Italy |
| Fondazione Istituto Neurologico Nationale C. Mondino | Pavia | 27100 | Italy |
| Boerhaave Medisch Centrum | Amsterdam | 1078 VV | Netherlands |
| Canisius-Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital ClÃnico Universitario de Valencia | Valencia | 46010 | Spain |
| Hull Royal Infirmary | Hull | East Yorkshire | HU3 2JZ | United Kingdom |
| Walton Centre for Neurology and Neurosurgery | Liverpool | Lancashire | L9 7LJ | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire | ST4 6QG | United Kingdom |
| Received at Least One Dose of Study Drug |
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| COMPLETED | Participants who continued until sponsor ended the study following regulatory approval or non-approval of study drug for cluster headache indication in a country/region. |
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| NOT COMPLETED |
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All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Galcanezumab 300 mg SC | Participants received 300 mg Galcanezumab administered SC up to once a month. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Region of Enrollment | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through End of Study (Up to 4 Years) |
|
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| ||||||||||||||||||||||||||||||||
| 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).
| All participants who received at least one dose of study drug and had at least one postbaseline C-SSRS assessment. | Posted | Count of Participants | Participants | No | 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:
| All participants who received at least one dose of study drug and had baseline and at least one post baseline ADA assessment. | Posted | Count of Participants | Participants | No | Baseline through End of Study (Up to 4 Years) |
|
|
Baseline through End of Study (Up to 4 Years)
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galcanezumab 300 mg SC | Participants received 300 mg Galcanezumab administered SC up to once a month. | 1 | 164 | 17 | 164 | 62 | 164 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Cartilage injury | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Exposure to household chemicals | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
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| Cluster headache | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment | This event was not captured in the C-SSRS suicidal behaviour count as the participant's responses to suicidal ideation/behaviours were "no" for all completed assessments. |
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| Ureterolithiasis | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Arterial occlusive disease | Vascular disorders | MedDRA 23.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 2, 2021 | Aug 4, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D006261 | Headache |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D020773 | Headache Disorders |
| D051270 | Headache Disorders, Primary |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D010146 | Pain |
| D051303 | Trigeminal Autonomic Cephalalgias |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000628360 | galcanezumab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Denmark |
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| Finland |
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| France |
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| Germany |
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| Greece |
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| Italy |
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| Netherlands |
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| Spain |
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| United Kingdom |
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| United States |
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