A Multicenter Assessment of LBR-101 in High Frequency Episodic Migraine

Inclusion Criteria:

- Males or females aged 18 to 65 years of age.

- A signed and dated informed consent document indicating that the subject has been
informed of all pertinent aspects of the study including any known and potential risks
and available alternative treatments.

- Subjects fulfilling criteria for episodic migraine as per the Second Edition of The
International Headache Society (Olesen and Steiner 2004), who experience migraine at
high frequency as follows:

i. History of headaches on more than 8 days per month for at least 3 months prior to
screening

ii. Verification of headache frequency through prospectively collected baseline information
during the 28-day run-in phase demonstrating headaches (of any type) on at least 8 days
with at total of 8 to 14 days* fulfilling criteria for migraine.

*Operational definition for migraine and probable migraine days are presented in the
statistical section of this protocol.

- Body Mass Index (BMI) of 17.5 to 37.5 kg/m2, and a total body weight between 50 kg and
120 kg, inclusive.

- Demonstrated compliance with the electronic headache diary during the run-in period by
entry of headache data on a minimum of 22/28 days (80% compliance).

Exclusion Criteria:

- Subject has received onabotulinum toxin A for migraine or for any medical or cosmetic
reasons requiring injections in the head, face, or neck during the six months prior to
screening.

- Subject uses medications containing opioids (including codeine) or barbiturates
(including Fiorinal®, Fioricet®, or any other combination containing butalbital) on
more than 4 days per month for the treatment of migraine or for any other reason.

- Failed > 2 medication categories or > 3 preventive medications (within two medication
categories) due to lack of efficacy for prophylactic treatment of episodic or chronic
migraine after an adequate therapeutic trial

- Treatment with an investigational drug or device within 30 days of study entry or any
prior exposure to a monoclonal antibody targeting the CGRP pathway.