A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention

INTERVENTION: Product Name: AMG 334 Product Code: AMG 334 Pharmaceutical Form: Solution for injection Current Sponsor code: AMG 334 Other descriptive name: AMG 334 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Prevention of chronic migraine ; MedDRA version: 18.0 Level: LLT Classification code 10027608 Term: Migraine, unspecified System Organ Class: 100000004852 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate the effect of AMG 334 compared to placebo on the change from baseline in monthly migraine days, in subjects with chronic migraine Primary end point(s): Change in monthly migraine days from baseline to the last 4 weeks of the; 12‐week double‐blind treatment phase Secondary Objective: Efficacy:; • To evaluate the effect of AMG 334, compared to placebo, on the proportion of subjects with at least 50% reduction from baseline in monthly migraine days, in subjects with chronic migraine; • To evaluate the effect of AMG 334, compared to placebo, as measured by the change from baseline on monthly migraine‐specific medication treatment usage; • To evaluate the effect of AMG 334 compared to placebo as measured by change from baseline on mothly cumulative hours of headache; Safety: To evaluate the safety and tolerability of AMG 334 Timepoint(s) of evaluation of this end point: Change in monthly migraine days from baseline to the last 4 weeks of the; 12‐week double‐blind treatment phase, calculated based on the following: (number of migraine days during the last 4 weeks of the double‐blind treatment phase, ie, between weeks 9 and 12) ‐ (number of migraine days during the 4‐week baseline phase); ; SECONDARY OUTCOME: Secondary end point(s): Efficacy: ; • At least a 50% reduction from baseline in monthly migraine days in the last 4 weeks of the 12‐week double‐blind treatment phase ; • Change from baseline on monthly migraine‐specific medication treatment days in the last 4 weeks of the 12‐week double‐blind treatment phase ; • Change from baseline in cumulative monthly headache hours in the last 4 weeks of the 12‐week double‐blind treatment phase ; ; Safety: ; • Adverse events ; • Clinical laboratory values and vital signs ; • Anti‐AMG 334 antibodies Timepoint(s) of evaluation of this end point: For full details, please refer to the schedule of assessments table in the protocol. INCLUSION CRITERIA: ‐ Adults = 18 to = 65 years of age upon entry into screening ‐ History of at least 5 attacks of migraine without aura and/or migraine with visual, sensory, speech and/or language, retinal or brainstem aura according to the IHS Classification ICHD‐III (Headache Classification Committee of the International Headache Society, 2013) based on medical records and/or patient self‐report ‐ History of = 15 headache days per month of which = 8 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening 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 622 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26