A Randomized, Multicenter, Dose-Blinded, Phase 2 Extension Study of ABP-450 (prabotulinumtoxinA) Purified Neurotoxin Complex for the Prevention of Migraine Headache
This Phase 2 Extension trial will evaluate the efficacy and safety of ABP-450 for migraine prevention in adults who suffer from six or more migraine days per month. The study will enroll approximately 666 patients across approximately 65 sites in the United States, Canada and Australia from the Phase 2 trial. Study subjects will be divided evenly across a low dose group and a high dose group. All patients will receive four treatment cycles of ABP-450 utilizing the Company's novel injection paradigm.
• Patient can understand the ICF, provides signed ICF and patient privacy information (eg, Authorization for Use and Release of Health and Research Study Information) before initiating any study-specific procedure, and agrees to comply with protocol requirements.
• Patient was enrolled in Study ABP-20001 and successfully completed that study's treatment and procedures.
• A WOCBP must be willing and able to use a medically acceptable and effective method of birth control, as determined by the investigator, during the entire study (Appendix 13.3).
• A WOCBP (Appendix 13.3) must have a negative urine pregnancy test at Visit 1.
• Patient can read, understand, and complete the eDiary.
• Patient is willing and able to adhere to the study assessments, visit schedules, and prohibitions, as described in this protocol.