A Study of Galcanezumab in Participants With Chronic Cluster Headache

NCT02438826 | Completed Phase 3 Results DMC

• 3 other identifiers: 15781I5Q-MC-CGAM2014-005429-11
• Study Type: interventional
• Target: 240
• Locations: 12 countries
• Sites: 48

Brief Summary

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic cluster headache.

Conditions

Chronic Cluster Headache

Outcome Measures

Primary Outcomes (1)

• Overall Mean Change From Baseline in Weekly Cluster Headache Attack Frequency

  Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary, Baseline and 12 weeks of daily data during double-blind treatment phase will be converted into 14-calendar day intervals: the baseline 14-day interval, Weeks 1/2, 3/4, 5/6, 7/8, 9/10, and 11/12. Next, the biweekly interval results were adjusted to 7-day (weekly) interval in order to report the outcome as weekly frequency. Overall mean change from baseline is derived from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, verapamil use, pooled investigative site, week, baseline, and treatment by week as fixed effects.

  Baseline, Week 1 through Week 12

Secondary Outcomes (13)

• Percentage of Participants With a 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks

  Baseline, Week 1 through Week 12

• Percentage of Participants With a Sustained Response of 50% or Greater Reduction From Baseline in the Weekly Number of Cluster Headache Attacks

  Baseline, Week 3 through Week 12

• Percentage of Participants With a 30% Reduction in the Weekly Number of Cluster Headache Attacks

  Baseline, Week 1 through Week 12

• Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

  Week 4

• Percentage of Participants Reporting a Score of 1 or 2 on the Patient Global Impression of Improvement (PGI-I)

  Week 8

Study Arms (2)

Galcanezumab 300 mg

EXPERIMENTAL

Double-Blind Treatment Phase: Participants received galcanezumab 300 mg once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.

Drug: Galcanezumab 300 mg

Placebo

PLACEBO COMPARATOR

Double-Blind Treatment Phase: Participants received placebo once a month by subcutaneous (SC) injection for 3 months. Open-Label Treatment Phase: Participants received 300 mg galcanezumab by subcutaneous injections every 30 days, for up to a total of 12 administrations.

Drug: Galcanezumab 300 mg; Drug: Placebo

Interventions

Galcanezumab 300 mg DRUG

Administered SC

Also known as: LY2951742

Galcanezumab 300 mg; Placebo

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a history of chronic cluster headache occurring without a remission period, or with remissions lasting \<1 month, for at least 1 year.
• Participants are able to distinguish cluster headache attacks from other headaches.

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.
• 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).
• Are taking indomethacin and/or are suspected of having another distinct trigeminal autonomic cephalalgia.
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (48)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Stanford University Hospital

Stanford, California, 94304, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Mayo Clinic-Jacksonville

Jacksonville, Florida, 32224, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Michigan Head, Pain and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007-4209, United States

Location

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Ghent, 9000, Belgium

Location

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Liège, 4000, Belgium

Location

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Montreal, H2L 4M1, Canada

Location

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Montreal, H2W 1V1, Canada

Location

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Toronto, M4S 1Y2, Canada

Location

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Glostrup Municipality, 2600, Denmark

Location

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Glostrup Municipality, 2600, Denmark

Location

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Helsinki, 00930, Finland

Location

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Turku, 20100, Finland

Location

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Lille, 59037, France

Location

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Marseille, 13385, France

Location

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Nice, 06003, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Paris, 75010, France

Location

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Paris, 75475, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Saint-Etienne, 42055, France

Location

Praxis Dr. Stude

Bochum, 44787, Germany

Location

Universtitätsklinikum Essen AöR

Essen, 45147, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Hamburg, 20246, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Jena, 07747, Germany

Location

Migräne- und Kopfschmerzklinik GmbH & Co. KG

Königstein, 61462, Germany

Location

Klinikum der Universität München Campus Großhadern

München, 81377, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Athens, 11525, Greece

Location

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Athens, 11528, Greece

Location

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Florence, 50134, Italy

Location

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Milan, 20133, Italy

Location

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Pavia, 27100, Italy

Location

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Amsterdam, 1078w, Netherlands

Location

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Nijmegen, 6532 SZ, Netherlands

Location

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Barcelona, 08035, Spain

Location

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Valencia, 46010, Spain

Location

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Hull, HU3 2JZ, United Kingdom

Location

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Liverpool, L9 7LJ, United Kingdom

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

London, SE5 9RS, United Kingdom

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Publications (2)

• Jensen RH, Tassorelli C, Myers Oakes TM, Bardos JN, Zhou C, Dong Y, Aurora SK, Martinez JM. Baseline demographics and disease characteristics of patients with episodic or chronic cluster headache: data from two phase 3 randomized clinical trials in Europe and North America. Front Neurol. 2023 Dec 15;14:1293163. doi: 10.3389/fneur.2023.1293163. eCollection 2023.

  PMID: 38162453 DERIVED

• Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM, Zhou C, Aurora SK, Yang JY, Conley RR, Oakes T. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020 Aug;40(9):935-948. doi: 10.1177/0333102420905321. Epub 2020 Feb 12.

  PMID: 32050782 DERIVED

Related Links

• Click here for more information about this study: A Study of LY2951742 in Participants With Chronic Cluster Headache

MeSH Terms

Conditions

Cluster Headache

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

Clinicaltrials.gov@lilly.com

800-545-5979

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2015
• First Posted: May 8, 2015
• Study Start: June 18, 2015
• Primary Completion: March 27, 2018
• Study Completion: August 14, 2019
• Last Updated: August 25, 2020
• Results First Posted: June 11, 2019

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

CA (3); GB (4); US (14); ES (2); DK (2); FI (2); IT (3); BE (2); FR (6); DE (6); GR (2); NL (2)