Main
|
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:
|
EUCTR |
Last refreshed on:
|
8 October 2021 |
Main ID: |
EUCTR2015-001883-21-NL |
Date of registration:
|
24/11/2015 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Evaluation of LY2951742 in the Prevention of Chronic Migraine
|
Scientific title:
|
A Phase 3, Randomized, Double-Blind, Placebo-Controlled
Study of LY2951742 in Patients with Chronic Migraine - the REGAIN Study - REGAIN |
Date of first enrolment:
|
18/01/2016 |
Target sample size:
|
825 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001883-21 |
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
|
Canada
|
Czech Republic
|
Germany
|
Israel
|
Italy
|
Korea, Republic of
|
Mexico
|
Netherlands
|
Puerto Rico
|
Spain
|
Taiwan
|
United Kingdom
|
United States
| |
Contacts
|
Name:
|
Clinical Trial Registry Office
|
Address:
|
Lilly Corporate Center
DC 1526
Indianapolis
United States |
Telephone:
|
|
Email:
|
EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
|
Eli Lilly |
|
Name:
|
Clinical Trial Registry Office
|
Address:
|
Lilly Corporate Center
DC 1526
Indianapolis
United States |
Telephone:
|
|
Email:
|
EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
|
Eli Lilly |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: Patients are 18 to 65 years of age (inclusive) at the time of screening.
Have a diagnosis of chronic migraine as defined by International
Headache Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta.
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 816 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
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, or to LY2951742.
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
|
Chronic Migraine Headache MedDRA version: 18.1
Level: LLT
Classification code 10027602
Term: Migraine headache
System Organ Class: 100000004852
|
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
|
Intervention(s)
|
Product Code: LY2951742 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: . Other descriptive name: LY2951742 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 120- Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use
|
Primary Outcome(s)
|
Main Objective: To test the hypothesis that at least one dose of LY2951742 is superior to placebo in the prevention of migraine headache in patients with chronic migraine.
|
Timepoint(s) of evaluation of this end point: Baseline period to month 3 of the double-blinded treatment phase.
|
Primary end point(s): Mean change in the number of migraine headache days during the 3 month double-blind treatment phase.
|
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 the migraine condition
|
Secondary Outcome(s)
|
Secondary end point(s): The proportion of patients with reduction from baseline =50% in
migraine headache days.
The proportion of patients with reduction from baseline =75% in monthly migraine headache days
during the 3-month double-blind treatment phase
The proportion of patients with reduction from baseline of 100% in monthly migraine headache days during the 3-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).
Assessment of change from baseline in the number of migraine headache days requiring medication for the acute treatment of migraine or headache.
Mean change from baseline in the Patient Global Impression of Severity (PGI-S) score at Month 3
|
Timepoint(s) of evaluation of this end point: Baseline to end of 3 month double-blinded treatment period.
|
Secondary ID(s)
|
I5Q-MC-CGAI
|
Source(s) of Monetary Support
|
Eli Lilly and Company
|
Ethics review
|
Status: Approved
Approval date: 18/01/2016
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|