PrimaryTo test the hypothesis that at least 1 dose of LY2951742 (120 or 240 mg/month) is superior to placebo in the prevention of migraine headache in patients with episodic migraine.Key Secondary ObjectivesIf LY2951742 (120 or 240 mg/month) is…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The overall mean change from baseline in the number of monthly migraine
headache days during the 6-month double-blind treatment phase
Secondary outcome
The specific methodology (including testing order, relationship and type I
error allocation and propagation) for the tests of the following key
secondary endpoints will be specified in the statistical analysis plan:
- The proportion of patients with reduction from baseline >=50% in monthly
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
-The mean change from baseline in the Role Function-Restrictive domain score of
the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1)
(average of Months 4, 5, and 6)
-The overall mean change from baseline in the number of monthly migraine
headache days requiring medication for the acute treatment of
migraine or headache during the 6-month doubleblind treatment phase
-The mean change from baseline in the Patient Global Impression of Severity
(PGI-S) score (average of Months 4, 5, and 6)
Background summary
Study I5Q-MC-CGAH (CGAH; EVOLVE-2) is intended to assess the efficacy and
safety of two doses of LY2951742 in the prevention of migraine headache
compared with placebo in patients suffering from episodic migraine. Episodic
migraine is defined as 4 to 14 migraine headache days (with or without aura)
per month.
Study objective
Primary
To test the hypothesis that at least 1 dose of LY2951742 (120 or 240 mg/month)
is superior to placebo in the prevention of migraine headache in patients with
episodic migraine.
Key Secondary Objectives
If LY2951742 (120 or 240 mg/month) is statistically significantly superior to
placebo on the primary objective, the following key secondary objectives will
be tested with adjustment for multiplicity (only the key secondary objectives
are listed below):
-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
Study design
A multisite, randomized, double-blind, parallel, placebo-controlled trial with
4 study periods in patients who meet International Classification of Headache
Disorders (ICHD) criteria for a diagnosis of migraine as confirmed during a
prospective baseline period that demonstrates episodic frequency (4 to 14
migraine headache days per month).
Intervention
Three treatment arms: LY2951742 (120 mg/month with a 240 mg loading dose at the
first injection [administered as 2 injections of 120 mg at Visit 3]), LY2951742
(240 mg/month, administered as 2 injections of 120 mg), and placebo. Following
a prospective baseline (30-40 days) period, eligible patients will be
randomized in a 2:1:1 ratio to receive placebo, 120 mg/month of LY2951742, or
240 mg/month of LY2951742, respectively, and will begin a 6-month treatment
phase. This phase will be followed by a 4-month, post-treatment phase during
which patients will
no longer receive any study medication.
Study burden and risks
The study drug is accompanied by certain risks. The most commonly observed
adverse events in studies in migraine patients were pain at the site of
injection and infection of the upper breathing system, such as bronchitis,
cold, or cold-like symptoms. More information about the known and expected
benefits, risks, serious adverse events (SAEs) and reasonably anticipated
adverse events (AEs) of LY2951742 are to be found in the Investigator*s
Brochure (IB).
The studyprocedures, including blood draws, also have certain risks. The study
drug, the study procedures and the combination may also have other, unknown
risks. The risks are described in the subject information sheet.
This current study is being carried out in a patient population for which the
drug already has shown preliminary evidence of efficacy and safety.
Papendorpseweg 83
Utrecht 3528 BJ
NL
Papendorpseweg 83
Utrecht 3528 BJ
NL
Listed location countries
Age
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.
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 (basilartype migraine) defined by IHS ICHD-3 beta.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-001882-17-NL |
| CCMO | NL55350.075.15 |