Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic
 migraine
This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in
 adult patients with episodic migraine. The subjects were randomized to receive either
 erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening
 period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline
 period. After randomization/Day 1, visits occurred at four week intervals until Week 12,
 which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety
 Follow-Up visit, which occurred 12 weeks later, at Week 24.
Key inclusion criteria:

 1. Documented history of migraine in the 12 months prior to screening

 2. 4-14 days per month of migraine symptoms

 3. >=80% diary compliance during the Baseline period

 Key exclusion criteria:

 1. >50 years old at migraine onset

 2. Pregnant or nursing

 3. History of cluster or hemiplegic headache

 4. Evidence of seizure or major psychiatric disorder

 5. Score of 19 or higher on the BDI

 6. Active chronic pain syndrome

 7. Cardiac or hepatic disease