Treatment-resistant Migraine MedDRA version: 20.0 Level: LLT Classification code 10027602 Term: Migraine headache System Organ Class: 100000004852
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are 18 to 75 years of age (inclusive) at the time of screening. Have a diagnosis of migraine as defined by IHS ICHD-3 guidelines (1.1, 1.2, or 1.3) (ICHD-3 2018), with a history of migraine headaches of at least 1 year prior to Visit 1, and migraine onset prior to age 50. Prior to Visit 1, have a history of at least 4 migraine headache days and at least 1 headache-free day per month on average within the past 3 months. Prior to Visit 1, have documentation (medical or pharmacy record or by physician’s confirmation) of previous failure to 2 to 4 migraine preventive medication categories in the past 10 years from the following list due to inadequate efficacy (that is, maximum tolerated dose for at least 2 months) and/or safety/tolerability reasons. a) propranolol or metoprolol b) topiramate c) valproate or divalproex d) amitriptyline e) flunarizine f) candesartan g) botulinum toxin A or B (if documented that botulinum toxin was taken for chronic migraine) h) medication locally approved for prevention of migraine 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 410 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
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 galcanezumab or another CGRP antibody. • 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. • Are currently receiving medication or other treatments for the prevention of migraine headaches. Patients must have discontinued such treatment at least 5 days prior to starting the baseline period. Botulinum toxin A and B that has been administered in the head or neck area for migraine prevention must be discontinued at least 3 months prior to starting the baseline period. Nerve block or device use (such as transcranial magnetic stimulation) in the head or neck area or for migraine prevention must be discontinued at least 30 days prior to starting the baseline period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that galcanezumab is superior to placebo in the prevention of migraine in patients with treatment-resistant migraine; Secondary Objective: To compare galcanezumab with placebo with respect to: • prevention of migraine in the episodic migraine subpopulation • 50% response rate • change in functioning • 75% response rate • 100% response rate • safety and tolerability ;Primary end point(s): The overall mean change from baseline in the number of monthly migraine headache days during the 3-month double-blind treatment phase in the total population (episodic and chronic migraine).;Timepoint(s) of evaluation of this end point: 3 month double blind treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The overall mean change from baseline in the number of monthly migraine headache days during the 3-month double-blind treatment phase in patients with episodic migraine • The percentage of patients with =50% reduction from baseline in monthly migraine headache days during the 3 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) at Month 3 • The percentage of patients with =75% reduction from baseline in monthly migraine headache days during the 3 month double-blind treatment phase • The percentage of patients with 100% reduction from baseline in monthly migraine headache days during the 3 month double-blind treatment phase • Analysis of: o treatment-emergent adverse events (TEAEs) o serious adverse events (SAEs) o discontinuation due to adverse events (AEs) o discontinuation rates o vital signs and weight o electrocardiograms (ECGs) o laboratory measures ;Timepoint(s) of evaluation of this end point: 3 month double blind treatment phase. | — |
Countries
Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed