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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02959177 |
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Date of registration:
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07/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 (Galcanezumab) in Japanese Patients With Episodic Migraine |
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Date of first enrolment:
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November 9, 2016 |
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Target sample size:
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459 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02959177 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 2
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Countries of recruitment
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Japan
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Migraine
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Intervention(s)
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Drug: Placebo
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Drug: Galcanezumab
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Primary Outcome(s)
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Overall Mean Change From Baseline in the Number of Monthly Migraine Headache Days (MHD)
[Time Frame: Baseline, Month 1 through Month 6]
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Secondary Outcome(s)
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Percentage of Participants Developing Anti-Drug Antibodies (ADA) to Galcanezumab
[Time Frame: Baseline through Month 6]
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Mean Change From Baseline in the Patient Global Impression of Severity (PGI-S) Score
[Time Frame: Baseline, Month 4 through Month 6]
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Mean Change From Baseline on the Migraine Disability Assessment Test (MIDAS) Total Score
[Time Frame: Baseline, Month 6]
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Overall Mean Change From Baseline on the Migraine-Specific Quality (MSQ) of Life Questionnaire
[Time Frame: Baseline, Month 4 through Month 6]
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Percentage of Participants With a 50% or Greater Reduction From Baseline in Monthly Migraine Headache Days
[Time Frame: Baseline, Month 1 through Month 6]
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Percentage of Participants With a 75% or Greater Reduction From Baseline in Monthly Migraine Headache Days
[Time Frame: Baseline, Month 1 through Month 6]
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Overall Mean Change From Baseline in Headache Hours
[Time Frame: Baseline, Month 1 through Month 6]
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Pharmacokinetics (PK): Serum Concentration of Galcanezumab
[Time Frame: Month 6]
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Percentage of Participants With a 100% Reduction From Baseline in Monthly Migraine Headache Days
[Time Frame: Baseline, Month 1 through Month 6]
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Percentage of Participants With Positive Responses on Patient Satisfaction With Medication Questionnaire-Modified (PSMQ-M)
[Time Frame: Month 6]
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Number of Participants With Suicidal Behaviors Assessed by Columbia - Suicide Severity Rating Scale (C-SSRS)
[Time Frame: Month 1 through Month 6]
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Overall Mean Change From Baseline in Number of Migraine Headache Days With Acute Medication Use
[Time Frame: Baseline, Month 1 through Month 6]
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Number of Participants With Suicidal Ideations Collected by Columbia - Suicide Severity Rating Scale (C-SSRS)
[Time Frame: Month 1 through Month 6]
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Total Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
[Time Frame: Month 6]
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Secondary ID(s)
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15796
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I5Q-JE-CGAN
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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