AJOVY® was evaluated
for registration in two
Phase III trials
including patients

with episodic or
chronic migraine2,3

The Phase III HALO studies with AJOVY® were designed to reflect real-world clinical practice2,3

≥84%

of patients were female2,3

 

>28%

of patients with chronic migraine had previously used topiramate3

 

≥20%

of patients were using concomitant preventive medications2,3

 

>17%

of patients with episodic migraine had previously used topiramate2

Patients with pre-existing myocardial infarction, cerebrovascular accident, and thromboembolic events were excluded. No safety data are available in these patients.1

Phase III trial designs

The HALO Phase III trials were randomised, double-blind, multicentre trials in patients with episodic or chronic migraine2,3

EM secondary endpoints:2

· Propotion of patients reaching ≥50% reduction from Baseline to Week 12 in monthly average number of migraine days

· Mean change from Baseline to Week 12 in the monthly average number of days of acute headache medication use

· Mean change from Baseline in the number of migraine days during the four-week period after the first dose

· Mean change from Baseline to Week 12 in the monthly average number of migraine days in patients not receiving

concomitant preventive migraine medications

· Mean change from Baseline in MIDAS disability score at four weeks after administration of last dose

CM secondary endpoints:3

· Mean change from Baseline to Week 12 in monthly average number of migraine days

· Proportion of patients reaching ≥50% reduction from Baseline to Week 12 in monthly average number of headache days of ≥moderate severity

· Mean change from Baseline to Week 12 in monthly average number of days of acute headache medication use

· Mean change from Baseline in the monthly average number of headache days of ≥moderate severity during the four-week period after the first dose

· Mean change from Baseline to Week 12 in the monthly average number of headache days of ≥moderate severity in patients not receiving

concomitant preventive migraine medications

· Mean change from Baseline in HIT-6 disability score at four weeks after administration of the last dose

 

*Patients were allowed to use one of the following: beta blocker, calcium chanel blocker/benzocycloheptene, antidepressant, anticonvulsant.1

Defined as a calendar day with either at least two (EM) or four (CM) consecutive hours of a headache meeting criteria for migraine (with or without aura); probable migraine (only one migraine criterion absent); or a day, regardless or duration, when acute migraine-specific medication (triptans or ergots) was used to treat a headache.2,3

Defined as a calendar day in which headache pain lasted at least four consecutive hours and had a peak severity of at least a moderate level, or a day in which acute migraine-specific medication (triptans or ergots) was used to treat a headache of any severity or duration.2,3

CM, chronic migraine; EM, episodic migraine; HIT-6 , six-item Headache Impact Test; MIDAS, Migraine Disability Assessment.

 

 

Suggestions to explore next

Continue to Efficacy page of AJOVY

Significantly more migraine-free days with AJOVY® vs placebo1-3

Clinical trial data for AJOVY®
Continue to Safety page of AJOVY

A generally well-tolerated treatment choice1-3

safety profile for ajovy®
Continue to Dosing flexibility page of AJOVY

Flexibility to help meet your patients' needs1

dosing options for ajovy®