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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. |
Register:
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EUCTR |
Last refreshed on:
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30 June 2019 |
Main ID: |
EUCTR2015-001882-17-NL |
Date of registration:
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24/11/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Evaluation of LY2951742 in the Prevention of Episodic Migraine
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Scientific title:
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY2951742 in Patients with Episodic Migraine - the EVOLVE-2 Study - EVOLVE-2 |
Date of first enrolment:
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18/01/2016 |
Target sample size:
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825 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001882-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Brazil
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Czech Republic
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Germany
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Israel
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Korea, Democratic People's Republic of
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Mexico
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Netherlands
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Puerto Rico
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Spain
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Taiwan
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
46285
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly |
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Name:
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Clinical Trial Registry Office
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Address:
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Lilly Corporate Center, DC 1526
46285
Indianapolis
United States |
Telephone:
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Email:
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EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
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Eli Lilly |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients are 18 to 65 years of age (inclusive)
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
Migraine onset prior to age 50.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 817 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
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 LY2951742 or another CGRP antibody
Are currently receiving medication or other treatments for the prevention of migraine headaches.
Known hypersensitivity to multiple drugs, monoclonal antibodies or
other therapeutic proteins
History of migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine defined by IHS ICHD-3 beta.
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:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Episodic Migraine Headache
MedDRA version: 18.1
Level: LLT
Classification code 10027602
Term: Migraine headache
System Organ Class: 100000004852
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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Intervention(s)
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Product Name: LY2951742 Product Code: LY2951742 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: . Current Sponsor code: LY2951742 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: To compare LY2951742 with placebo with respect to 50% response rate To compare LY2951742 with placebo with respect to 75% response rate To compare LY2951742 with placebo with respect to 100% response rate To compare LY2951742 with placebo with respect to change in functioning To compare LY2951742 with placebo with respect to change in use of acute (abortive) migraine treatment To compare LY2951742 with placebo with respect to change in global severity of migraine condition
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Primary end point(s): The overall mean change from baseline in the number of monthly migraine headache days during the 6-month double-blind treatment phase
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Timepoint(s) of evaluation of this end point: 6-month double-blind treatment phase
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Main Objective: To test the hypothesis that at least 1 dose of LY2951742 is superior to placebo in the prevention of migraine headache in patients with episodic migraine.
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Secondary Outcome(s)
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Secondary end point(s): The proportion of patients with reduction from baseline =50% in migraine headache days during the 6-month double-blind treatment phase
The proportion of patients with reduction from baseline =75% in monthly migraine headache days during the 6-month double-blind treatment phase
The proportion of patients with a 100% reduction from baseline in monthly migraine headache days during the 6-month double-blind treatment phase
Mean change from baseline in the total score of the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) (average of Months 4, 5 and 6)
Mean change from baseline in the number of migraine headache days requiring medication for the acute treatment of migraine or headache during the 6-month double-blind treatment phase
The mean change from baseline in the Patient Global Impression of Severity (PGI-S) score (average of Months 4, 5, and 6)
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Timepoint(s) of evaluation of this end point: 6-month double-blind treatment phase
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Secondary ID(s)
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I5Q-MC-CGAH
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Source(s) of Monetary Support
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Eli Lilly and Company
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Ethics review
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Status: Approved
Approval date:
Contact:
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