Episodic Migraine Headache MedDRA version: 20.0 Level: LLT Classification code 10027602 Term: Migraine headache System Organ Class: 100000013920
Conditions
Interventions
Product Name: Galcanezumab
Product Code: LY2951742
Pharmaceutical Form: Solution for injection in pre-filled syringe
Current Sponsor code: LY2951742
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Brazil, Czech Republic, Germany, Israel, Korea, Democratic People's Republic of, Mexico, Netherlands, Puerto Rico, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed