Long-Term Safety and Tolerability of OnabotulinumtoxinA Treatment in Chronic Migraine Patients: COMPEL Analysis by Treatment Cycle (P4.123)

Objective: Safety and tolerability of onabotulinumtoxinA were assessed in adults with chronic migraine (CM) in the COMPEL study. Background: The COMPEL study was a multicenter, open-label study evaluating efficacy and safety of onabotulinumtoxinA in adults with CM over 9 treatment cycles (108 weeks). Design/Methods: OnabotulinumtoxinA 155 U was administered every 12 weeks. The primary outcome was the reduction in headache day frequency at week 108 compared to baseline. Safety and tolerability, overall and by treatment cycle, were assessed. Any adverse event (AE) with a start day or increase in severity in the period between successive treatments was attributed to the preceding treatment. The safety population consisted of all patients who received ≥1 dose of onabotulinumtoxinA. Results: 716 patients were enrolled; the majority were Caucasian (81.3%) and women (84.8%). The mean (SD) age was 43 (11.3) years. 373 patients (52.1%) completed the study; 343 (47.9%) withdrew, primarily due to withdrawal of consent (n=92, 12.8%), loss to follow-up (n=82, 11.5%), and protocol violation (n=60, 8.4%). OnabotulinumtoxinA significantly reduced headache day frequency (n=715) by 10.7 (6.4) days, P Conclusions: COMPEL study results demonstrated that the incidence of overall AEs and the most common AEs decreased with repeated administration of onabotulinumtoxinA. Study Supported by: Allergan plc Disclosure: Dr. Brin has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan plc. Dr. Brin holds stock and/or stock options in Allergan plc, which sponsored research in which Dr. Brin was involved as an investigator. Dr. Brin holds stock and/or stock options in Allergan plc. Dr. Winner has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Consulting fees/honoraria from Allergan, Amgen, Supernus, has served on the speaker’s bureau for Allergan, Avanir, Supernus. Dr. Winner has received research support from Allergan, Amgen, NuPathe, AstraZeneca, Avanir, Eli Lilly, Novartis. Dr. Blumenfeld has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Served on advisory boards and/or has consulted for Allergan, Pernix, Teva, Avanir, Depomed, and Supernus, and has received funding for travel, speaking, and/or royalty payments from Allergan. Dr. Blumenfeld has received royalty, license fees, or contractual rights payments from For travel, speaking, and/or royalty payments from Allergan. Dr. Eross has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan, Avinar, Depomed, Pernix. Dr. Eross has received compensation for serving on the Board of Directors of Owner and President of Glia Sciences, Inc. Dr. Eross has received research support from Allergan. Dr. Orejudos has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan plc. Dr. Manack Adams has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Allergan plc. Dr. Manack Adams holds stock and/or stock options in Allergan plc, which sponsored research in which Dr. Manack Adams was involved as an investigator. Dr. Manack Adams holds stock and/or stock options in Allergan plc.