An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

Inclusion Criteria:

- The patient has a diagnosis of migraine with onset at ≤50 years of age.

- Body weight ≥45 kg

- The patient has a history of migraine for ≥12 months prior to screening.

- Women of childbearing potential (WOCBP) whose male partners are potentially fertile
(ie, no vasectomy) must use highly effective birth control methods for the duration of
the study and the follow-up period and for 6.0 months after discontinuation of
investigational medicinal product (IMP)

- Men must be sterile, or if they are potentially fertile/reproductively competent (not
surgically [eg, vasectomy] or congenitally sterile) and their female partners are of
childbearing potential, must use, together with their female partners, acceptable
birth control methods for the duration of the study and for 6.0 months after
discontinuation of the investigational medicinal product (IMP).

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- At the time of screening visit, patient is receiving any preventive migraine
medications, regardless of the medical indication for more than 5 days and expects to
continue with these medications.

- Patient has received onabotulinumtoxinA for migraine or for any medical or cosmetic
reasons requiring injections in the head, face, or neck during the 3 months before
screening visit.

- The patient has used an intervention/device (eg, scheduled nerve blocks and
transcranial magnetic stimulation) for migraine during the 2 months prior to
screening.

- The patient uses triptans/ergots as preventive therapies for migraine.

- Patient uses non-steroidal anti-inflammatory drugs (NSAIDs) as preventive therapy for
migraine on nearly daily basis for other indications. Note: Low dose aspirin (eg, 81
mg) used for cardiovascular disease prevention is allowed.

- Additional criteria apply, please contact the investigator for more information