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A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine

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ClinicalTrials.gov Identifier: NCT02959177
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to determine the efficacy of the study drug Galcanezumab in Japanese participants with episodic migraine.

Condition or disease Intervention/treatment Phase
Migraine Drug: Galcanezumab Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 451 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine
Study Start Date : November 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Dose Level 1 Galcanezumab
Galcanezumab administered subcutaneously (SC) once a month for 6 months.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742

Experimental: Dose Level 2 Galcanezumab
Galcanezumab administered SC once a month for 6 months.
Drug: Galcanezumab
Administered SC
Other Name: LY2951742

Placebo Comparator: Placebo
Placebo administered SC once a month for 6 months.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Mean Change from Baseline in the Number of Monthly Migraine Headache Days [ Time Frame: Baseline, Month 6 ]

Secondary Outcome Measures :
  1. Proportion of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days [ Time Frame: Month 6 ]
  2. Mean Change from Baseline on the Migraine-Specific Quality of Life Questionnaire [ Time Frame: Baseline, Month 6 ]
  3. Mean Change from Baseline in the Number of Monthly Migraine Headache Days or Headache Days Requiring Medication for the Acute Treatment of Migraine or Headache [ Time Frame: Baseline, Month 6 ]
  4. Mean Change from Baseline in the Patient Global Impression of Severity (PGI-S) Score [ Time Frame: Baseline, Month 6 ]
  5. Mean Change from Baseline in Headache Hours [ Time Frame: Baseline, Month 6 ]
  6. Mean Change from Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score [ Time Frame: Baseline, Month 6 ]
  7. Satisfaction with Medication Using the Participant Satisfaction with Medication Questionnaire-Modified (PSMQ-M) [ Time Frame: Month 6 ]
  8. Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline through Month 6 ]
  9. Percentage of Participants Developing Anti-Drug Antibodies to Galcanezumab [ Time Frame: Baseline through Month 6 ]
  10. Pharmacokinetics (PK): Serum Concentration of Galcanezumab [ Time Frame: Baseline through Month 6 ]
  11. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) [ Time Frame: Baseline through Month 6 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines (1.1 or 1.2) (ICHD-3 2013), with a history of migraine headaches of at least 1 year prior to screening, and migraine onset prior to age 50.

Exclusion Criteria:

  • 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 other antibodies to CGRP or its receptor.
  • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to Galcanezumab and the excipients in the investigational product.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959177


Locations
Japan
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.
Chiba, Japan, 275-0026
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Chofu-shi, Japan, 182-0006
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Fukui, Japan, 918 8503
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Fukui, Japan, 9188503
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Fukuoka, Japan, 816 0824
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Higashioka, Japan, 578-8588
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Hiroshima, Japan, 730-0031
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Iruma-Gun, Japan, 350-0495
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Kagoshima, Japan, 892-0842
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Kasaoka-shi, Japan, 714-0043
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Kawasaki, Japan, 211-8588
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Kawasaki, Japan, 2118588
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Kobe, Japan, 658-0064
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Kobe, Japan, 6580064
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Kochi, Japan, 780-8011
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Kyoto, Japan, 600-8811
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Kyoto, Japan, 606-0851
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Kōchi, Japan, 780-0051
"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."
Matsuyama, Japan, 790-0925
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Matsuyama, Japan, 790-0925
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Minato-Ku, Japan, 108-8642
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Minatoku, Japan, 1088642
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Morioka, Japan, 020-0034
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Morioka, Japan, 020-8505
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.
Morioka, Japan, 0200034
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Niigata, Japan, 9493193
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Nishinomiya, Japan, 663-8014
"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."
Nishinomiya, Japan, 663-8204
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Nishinomiya, Japan, 663-8204
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Oita, Japan, 870-0831
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Okayama-shi, Japan, 700-8557
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Osaka-Shi, Japan, 556-0015
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Ota-shi, Japan, 373-8585
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Saijo-shi, Japan, 793-0030
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Saitama, Japan, 338 8577
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Sapporo, Japan, 003-0003
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Sapporo, Japan, 060-8570
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Sendai, Japan, 982-0014
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Shibuya-ku, Japan, 151-0051
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Shinjuku-ku, Japan, 160-0017
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Shizuoka, Japan, 420-0853
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Tachikawa-shi, Japan, 190-8531
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Tokyo, Japan, 160-8582
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Tōyama, Japan, 9300803
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Yamaguchi, Japan, 754-0002
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Yamanashi, Japan, 400-0124
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Yamanashi, Japan, 4000124
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02959177     History of Changes
Other Study ID Numbers: 15796
I5Q-JE-CGAN ( Other Identifier: Eli Lilly and Company )
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Keywords provided by Eli Lilly and Company:
prevention
prophylaxis
headache

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases