NCT02397473

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as Galcanezumab in participants with episodic cluster headaches.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

Geographic Reach
12 countries

47 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 22, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 13, 2019

Completed
Last Updated

September 9, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

March 19, 2015

Results QC Date

February 8, 2019

Last Update Submit

August 26, 2019

Conditions

Episodic Cluster Headache

Outcome Measures

Primary Outcomes (1)

  • Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks

    Number of cluster headache attacks was recorded daily by study participants in their ePRO Diary. Overall mean change from baseline is derived from the average of weeks 1 to 3 from mixed model repeated measures (MMRM) analysis. Least Square (LS) means were calculated using MMRM model with treatment, sex, pooled investigative site, week, baseline, and treatment by week as fixed effects.

    Baseline, Week 1 through Week 3

Secondary Outcomes (11)

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

    Baseline, Week 3

  • Overall Mean Change From Baseline in Number of Weekly Cluster Headache Attacks

    Baseline, Week 1 through Week 8

  • 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

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

    Baseline, Week 1 through Week 8

  • +6 more secondary outcomes

Study Arms (2)

Galcanezumab 300mg

EXPERIMENTAL

Galcanezumab 300mg administered subcutaneously (SC) every 30 days during an 8 week treatment period.

Drug: Galcanezumab

Placebo

PLACEBO COMPARATOR

Placebo administered SC every 30 days during an 8 week treatment period.

Drug: Placebo

Interventions

GalcanezumabDRUG

Administered SC

Also known as: LY2951742
Galcanezumab 300mg
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of cluster headache as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with a history of episodic cluster headache with at least two cluster periods lasting from 7 days to 1 year (when untreated) and separated by pain-free remission periods of \>=1 month.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University Hospital

Palo Alto, California, 94304, United States

Location

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Colorado Neurological Institute

Englewood, Colorado, 80113, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Mayo Clinic-Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

St. Anthony's Hospital

St. Petersburg, Florida, 33705, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Atlanta Center of Medical Research

Atlanta, Georgia, 30331, United States

Location

Michigan Head, Pain, and Neurological Institute

Ann Arbor, Michigan, 48104, United States

Location

ClinVest

Springfield, Missouri, 65807, United States

Location

Dent Neurological Institute

Amherst, New York, 14226, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Clinical Trials of South Carolina

Charleston, South Carolina, 29406, 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

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.

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

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.

Toronto, M4S IY2, Canada

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.

Glostrup Municipality, 2600, Denmark

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.

Helsinki, 00930, Finland

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.

Jyväskylä, 40100, Finland

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.

Turku, 20100, Finland

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.

Lille, 59037, 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.

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

"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."

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

Uniklinikum 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

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Athens, 11525, Greece

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.

Athens, 11528, Greece

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.

Florence, 50134, Italy

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.

Milan, 20133, Italy

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.

Pavia, 27100, Italy

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.

Amsterdam, 1078 VV, Netherlands

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.

Nijmegen, 6532 SZ, Netherlands

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.

A Coruña, 15706, Spain

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.

Barcelona, 08035, Spain

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.

Valencia, 46010, Spain

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.

Hull, HU3 2JZ, 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.

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

Related Publications (3)

  • 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: 38162453DERIVED

  • Andrews JS, Kudrow D, Rettiganti M, Oakes T, Bardos JN, Wenzel R, Kuruppu DK, Gaul C, Martinez JM. Impact of Galcanezumab on Total Pain Burden: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study in Patients with Episodic Cluster Headache. J Pain Res. 2021 Jul 8;14:2059-2070. doi: 10.2147/JPR.S305066. eCollection 2021.

    PMID: 34267550DERIVED

  • Goadsby PJ, Dodick DW, Leone M, Bardos JN, Oakes TM, Millen BA, Zhou C, Dowsett SA, Aurora SK, Ahn AH, Yang JY, Conley RR, Martinez JM. Trial of Galcanezumab in Prevention of Episodic Cluster Headache. N Engl J Med. 2019 Jul 11;381(2):132-141. doi: 10.1056/NEJMoa1813440.

    PMID: 31291515DERIVED

Related Links

MeSH Terms

Conditions

Cluster Headache

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous 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
OTHER
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

March 19, 2015

First Posted

March 25, 2015

Study Start

May 22, 2015

Primary Completion

February 12, 2018

Study Completion

June 4, 2018

Last Updated

September 9, 2019

Results First Posted

March 13, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

FR(5)US(17)DK(1)IT(3)GR(2)NL(2)ES(3)GB(3)BE(2)CA(2)FI(3)DE(4)