Evaluation of LY2951742 in the Prevention of Episodic Migraine

• Register: EUCTR
• Last refreshed on: 24 January 2022
• Main ID: EUCTR2015-001882-17-DE
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: Evaluation of LY2951742 in the Prevention of Episodic Migraine
• Scientific title: 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: 07/03/2016
• Target sample size: 825
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001882-17
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Brazil, Czech Republic, Germany, Israel, Korea, Democratic People's Republic of, Mexico, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

• Name: Clinical Trial Registry Office
• Affiliation: Eli Lilly

Key inclusion & exclusion criteria

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
Failure to respond to 3 or more adequately dosed migraine preventive treatments
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

Health Condition(s) or Problem(s) studied

Episodic Migraine Headache
MedDRA version: 20.0 Level: LLT Classification code 10027602 Term: Migraine headache System Organ Class: 100000004852

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Galcanezumab
Product Code: LY2951742
Pharmaceutical Form: Solution for injection in pre-filled syringe
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

Primary Outcome(s)

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.

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

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

Timepoint(s) of evaluation of this end point: 6-month double-blind treatment phase

Secondary Outcome(s)

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)

Timepoint(s) of evaluation of this end point: 6-month double-blind treatment phase

Secondary ID(s)

I5Q-MC-CGAH(a)

2015-001882-17-NL

Source(s) of Monetary Support

Eli Lilly and Company

Ethics review

Status: Approved
Approval date: 07/03/2016
Contact:

Results

• Results available: Yes
• Date Posted: 18/10/2019
• Date Completed: 05/10/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-001882-17/results