A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate
the Efficacy and Safety of AMG 334 in Migraine Prevention

Migraine is a profound disabling disorder, aanvalsgewijze hoofdpijnaandoening
met een eenjaarsprevalentie van 15-20% in de Nederlandse populatie. Migraine
is in the top 10 of the WHO most disabling diseases and belongs to the priority
list of under treated, serious disabling brain diseases. Migraine profylaxis is
an area with a large "unmedcial need*. Calcitonine Gene Related Peptide (CGRP)
receptor antagonisme seems a good candidate to change that. The investigated
product AMG334 is an antagonist of the CGRP receptor by which it (besides other
effects) could diminish vasodilatation, pain transmission and inflammation in
the brain and therefore could reduce migraine attacks.

To evaluate the effect of AMG 334 compared to placebo on the change from
baseline in mean monthly migraine days, in subjects with episodic migraine.

hypothesis: In subjects with episodic migraine, AMG 334 has a greater reduction
from baseline in mean monthly migraine days, compared to placebo. The
anticipated treatment effect of AMG 334 compared to placebo is 1.12 and 1.30
monthly migraine days mean reduction from baseline for 70 mg and 140 mg,
respectively.

Phase 3, multicenter, randomized, stratified, double-blind, placebo-controlled,
parallel-group study of subjects with episodic migraine. Approximately 852
subjects will be randomized 1:1:1 to placebo, AMG 334 70 mg, or AMG 334 140 mg.
NEW: The randomization will be stratified by region (North America vs Other)
and treatment status with migraine prophylactic medication (a. current migraine
prophylactic medication treatment; b. prior migraine prophylactic medication
treatment only; c.no prior migraine prophylactic medication treatment).

After signing informed consent, subjects will enter the screening phase. The
screening phase is composed of an initial screening phase (up to 3 weeks)
followed by a 4-week baseline phase. At the day 1 visit, eligible subjects will
be enrolled (ie, randomized) into the 24-week double-blind treatment phase and
will begin to receive double-blind investigational product QM SC. At the week
24 visit, subjects in each treatment group will be re-randomized 1:1 to AMG 334
70 mg or AMG 334 140 mg for the 28-week active treatment phase and will begin
to receive investigational product QM SC that remains blinded for the dose
level only. A safety follow-up visit occurs 16 weeks after the last dose of
investigational product. Subjects will use an electronic diary (eDiary) every
day throughout the baseline phase, double-blind treatment phase and active
treatment phase to report information about their migraine and non-migraine
headaches and acute headache medication use. Subjects will have scheduled
in-clinic study
visits monthly from week -4 through the end of the active treatment phase.

After signing informed consent, subjects will enter the screening phase. The
screening phase is composed of an initial screening phase (up to 3 weeks)
followed by a 4-week
baseline phase. At the day 1 visit, eligible subjects will be enrolled (ie,
randomized) into the
24-week double-blind treatment phase and will begin to receive double-blind
investigational
product QM SC. At the week 24 visit, subjects in each treatment group will be
re-randomized 1:1
to AMG 334 70 mg or AMG 334 140 mg for the 28-week active treatment phase and
will begin to
receive investigational product QM SC that remains blinded for the dose level
only. A safety
follow-up visit occurs 16 weeks after the last dose of investigational product.
Subjects will use an
electronic diary (eDiary) every day throughout the baseline phase, double-blind
treatment phase
and active treatment phase to report information about their migraine and
non-migraine
headaches and acute headache medication use. Subjects will have scheduled
in-clinic study
visits monthly from week -4 through the end of the active treatment phase.
For a full list of study procedures, including the timing of each procedure,
please refer to
Section 7 and the Schedule of Assessments (Table 1).