A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

• Status: Completed
• Trial end date: 2017-05-26
• Target enrollment: 0
• Participant gender: All

Summary

To assess the long-term safety and efficacy of erenumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Erenumab

Criteria

Inclusion Criteria:

1. Subject has provided informed consent prior to initiation of any study-specific activities/procedures

2. Completed the 12-week study visit and did not end IP early during the double-blind treatment period of the AMG 334 20120295 (NCT02066415) parent study, and is appropriate for continued treatment.

Exclusion Criteria:

1. Development of any unstable or clinically significant medical condition, laboratory or electrocardiogram (ECG) abnormality following randomization into the parent study, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.

2. Systolic blood pressure (BP) 160 mm Hg and/or diastolic BP 100 mm Hg or greater at screening/Day 1.

3. Subject who used excluded concomitant medications between week 8 and week 12 of the parent study