NCT02614287

Brief Summary

The main purpose of this study is to evaluate the longer term safety of the study drug known as galcanezumab in participants with episodic or chronic migraine.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Typical duration for phase_3

Geographic Reach
6 countries

27 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

November 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 30, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

January 7, 2019

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

November 23, 2015

Results QC Date

August 23, 2018

Last Update Submit

June 10, 2020

Conditions

Migraine

Keywords

preventionprophylaxisheadache

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Discontinued Due to Adverse Event

    Adverse Event: Any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A summary of other non-serious AEs, and all SAE's, regardless of causality, is reported in the Adverse Events section.

    Baseline through Month 12

Secondary Outcomes (13)

  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of Galcanezumab

    Baseline through Month 12

  • Serum Concentrations of Galcanezumab

    Month 12

  • Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

    Month 12

  • Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab

    Month 1 through Month 12

  • Overall Mean Change From Baseline in the Number of Migraine Headache Days (MHD)

    Baseline, Month 1 through Month 12

  • +8 more secondary outcomes

Study Arms (2)

Galcanezumab 120 mg

EXPERIMENTAL

Galcanezumab 240mg given as loading dose at first dosing visit followed by 120 mg given by subcutaneous (SC) injection once a month for up to 11 months by auto injector or pre-filled syringe.

Drug: Galcanezumab

Galcanezumab 240 mg

EXPERIMENTAL

Galcanezumab 240 mg given by SC injection once a month for up to 12 months by auto injector or pre-filled syringe.

Drug: Galcanezumab

Interventions

GalcanezumabDRUG

Administered SC

Also known as: LY2951742
Galcanezumab 120 mgGalcanezumab 240 mg

Eligibility Criteria

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

You may qualify if:

  • Have a diagnosis of episodic or chronic migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.
  • Prior to baseline, a history of 4 or more migraine headache days per month on average for the past 3 months.

You may not qualify if:

  • Are currently enrolled in or have participated within the last 30 days or within 5 half-lives (whichever is longer) in a clinical trial involving an investigational product.
  • Current use or prior exposure to galcanezumab or another CGRP antibody.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab.
  • History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

California Medical Clinic for Headache

Santa Monica, California, 90404, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Sunrise Clinical Research

Hollywood, Florida, 33021, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Mercy Health Research

St Louis, Missouri, 63141, United States

Location

Albuquerque Neurosciences

Albuquerque, New Mexico, 87109, United States

Location

PharmQuest

Greensboro, North Carolina, 27408, United States

Location

Wilmington Health Associates

Wilmington, North Carolina, 28401, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Clinpoint Trial, LLC

Waxahachie, Texas, 75165, United States

Location

Ericksen Research and Development

Clinton, Utah, 84015, United States

Location

Blue Ridge Research Center

Roanoke, Virginia, 24018, 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bruges, 8000, 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Brussels, 1090, 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 from 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.

Calgary, T3M 1M4, 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.

Sherbrooke, J1H1Z1, 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 1Y2, 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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Marseille, 13385, 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.

Nice, 6000, 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, 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.

Saint-Etienne, 42055, 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.

Budapest, 1083, Hungary

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.

Esztergom, 2500, Hungary

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.

Győr, 9023, Hungary

Location

Ponce School of Medicine CAIMED Center

Ponce, 00716, Puerto Rico

Location

Related Publications (4)

  • Stauffer VL, Turner I, Kemmer P, Kielbasa W, Day K, Port M, Quinlan T, Camporeale A. Effect of age on pharmacokinetics, efficacy, and safety of galcanezumab treatment in adult patients with migraine: results from six phase 2 and phase 3 randomized clinical trials. J Headache Pain. 2020 Jun 23;21(1):79. doi: 10.1186/s10194-020-01148-9.

    PMID: 32576229DERIVED

  • Bangs ME, Kudrow D, Wang S, Oakes TM, Terwindt GM, Magis D, Yunes-Medina L, Stauffer VL. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020 Jan 17;20(1):25. doi: 10.1186/s12883-020-1609-7.

    PMID: 31952501DERIVED

  • Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020 Feb;60(2):229-239. doi: 10.1002/jcph.1511. Epub 2019 Sep 4.

    PMID: 31482569DERIVED

  • Camporeale A, Kudrow D, Sides R, Wang S, Van Dycke A, Selzler KJ, Stauffer VL. A phase 3, long-term, open-label safety study of Galcanezumab in patients with migraine. BMC Neurol. 2018 Nov 9;18(1):188. doi: 10.1186/s12883-018-1193-2.

    PMID: 30413151DERIVED

Related Links

MeSH Terms

Conditions

Migraine DisordersHeadache

Interventions

galcanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 25, 2015

Study Start

November 30, 2015

Primary Completion

May 12, 2017

Study Completion

August 14, 2018

Last Updated

June 17, 2020

Results First Posted

January 7, 2019

Record last verified: 2020-06

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

US(13)FR(4)BE(3)CA(3)HU(3)PR(1)