Ng Zhao4, Andrew M. Blumenfeld5 1 George Washington College of Medicine, Washington, DC, 20037, USA; two Global Healthcare Affairs, Allergan plc, Irvine, CA, 92623-9534, USA; three Bioststistics, Allergan plc, Irvine, CA, 92623-9534, USA; 4Statistics, Pharmaceutical Item Improvement, LLC, Austin TX, 78744, USA; 5 Headache Center of Southern California, The Neurology Center, Carlsbad, CA, 92024, USA Correspondence: John F. Rothrock ([email protected]) The Journal of Headache and Pain 2017, 18(Suppl 1):P9 Background To compare the efficacy, security, and tolerability of onabotulinumtoxinA and topiramate for preventive treatment of chronic migraine (CM) in adults. Materials and Strategies The FORWARD Study randomized adults with CM (1:1) to obtain 155 U onabotulinumtoxinA each and every 12 weeks ( days) for 3 remedy cycles or topiramate 50-100 mgday administered up to week 36. TFV-DP Reverse Transcriptase patients who discontinued topiramate at any time have been allowed the choice of crossing-over to acquire onabotulinumtoxinA at the next scheduled workplace stop by (week 12 up to week 36; Fig. 1). The major efficacy measure was a dichotomous variable (respondernonresponder) defined as the proportion of patients with 50 reduction in headache days in the course of the 28-day period ahead of week 32 (weeks 29-32). A baseline final observation carried forward imputation strategy was utilized to impute missing data replacing the missing value with the baseline value in the event the responder rate was missing at week 32 for any cause. Adverse events (AEs) had been monitored. Security information include AEs from randomization and cross-over phases. Final results 282 patients have been enrolled (onabotulinumtoxinA, n=140; topiramate, n=142) at 35 US web-sites. Patients had been mainly female (n=239, 84.8 ); imply (SD) baseline headache days (onabotulinumtoxinA, 22.1 [4.6]; topiramate, 21.eight [4.8]) had been comparable across remedy groups. 148 Cyclohexanecarboxylic acid manufacturer sufferers completed therapy as randomized (onabotulinumtoxinA, n=120 [85.7 ]; topiramate, n=28 [19.7 ]) by way of week 32. Primary reasons for withdrawal were ineffective therapy (onabotulinumtoxinA, n=7 [5.0 ]; topiramate, n=28 [19.7 ]) and AEs (onabotulinumtoxinA, n=5 [3.six ]; topiramate, n=72 [50.7 ]). 80 topiramate sufferers crossed-over to onabotulinumtoxinA. OnabotulinumtoxinA demonstrated drastically larger proportion of patients with 50 reduction in headache frequency in comparison to baseline vs topiramate (40.0 vs 12.0 , respectively; adjusted OR, five.0 [95 CI, 2.7-9.2]; P0.001) at the week-32 assessment.The Journal of Headache and Pain 2017, 18(Suppl 1):Web page 26 ofAEs have been reported by 45.five of onabotulinumtoxinA and 76.eight of topiramate patients; significant AEs by 1.4 and 4.two , respectively. Only sinusitis was reported in five of 220 patients getting onabotulinumtoxinA at any time; a variety of individual AEs have been reported in five getting topiramate (Table 1). Treatment-related AEs had been reported by 17.3 of onabotulinumtoxinA and 69.0 of topiramate sufferers. One severe AE (nephrolithiasis) was reported as connected to topiramate. Conclusions In this open-label study, preventive remedy of adults with CM with onabotulinumtoxinA demonstrated a much more favorable tolerability profile than topiramate. When employing imputation methods accounting for variations in discontinuation prices, onabotulinumtoxinA was additional effective than topiramate determined by 50 responder rates and headache day reduction. Funding Allergan plc Trial Registration ClinicalTrials.gov, NCT02191579 Table 1 (abstract P9). Adverse events in five of Patie.