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Ng Zhao4, Andrew M. Blumenfeld5 1 George Washington School of Medicine, Washington, DC, 20037, USA; 2 International Medical Affairs, Allergan plc, Irvine, CA, 92623-9534, USA; 3 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 evaluate the efficacy, safety, and tolerability of onabotulinumtoxinA and Linuron In Vivo topiramate for preventive therapy of chronic migraine (CM) in adults. Materials and Procedures The FORWARD Study randomized adults with CM (1:1) to obtain 155 U onabotulinumtoxinA just about every 12 weeks ( days) for three therapy cycles or topiramate 50-100 mgday administered up to week 36. Sufferers who discontinued topiramate at any time had been allowed the selection of crossing-over to acquire onabotulinumtoxinA in the next scheduled office go to (week 12 as much as week 36; Fig. 1). The key efficacy SC66 Apoptosis measure was a dichotomous variable (respondernonresponder) defined as the proportion of sufferers with 50 reduction in headache days during the 28-day period just before week 32 (weeks 29-32). A baseline last observation carried forward imputation strategy was utilized to impute missing information replacing the missing worth using the baseline value in the event the responder price was missing at week 32 for any reason. Adverse events (AEs) have been monitored. Security data include AEs from randomization and cross-over phases. Results 282 individuals had been enrolled (onabotulinumtoxinA, n=140; topiramate, n=142) at 35 US web pages. Patients were mainly female (n=239, 84.8 ); imply (SD) baseline headache days (onabotulinumtoxinA, 22.1 [4.6]; topiramate, 21.8 [4.8]) have been related across treatment groups. 148 individuals completed treatment as randomized (onabotulinumtoxinA, n=120 [85.7 ]; topiramate, n=28 [19.7 ]) by way of week 32. Principal motives for withdrawal have been ineffective remedy (onabotulinumtoxinA, n=7 [5.0 ]; topiramate, n=28 [19.7 ]) and AEs (onabotulinumtoxinA, n=5 [3.six ]; topiramate, n=72 [50.7 ]). 80 topiramate individuals crossed-over to onabotulinumtoxinA. OnabotulinumtoxinA demonstrated substantially higher proportion of individuals with 50 reduction in headache frequency in comparison to baseline vs topiramate (40.0 vs 12.0 , respectively; adjusted OR, five.0 [95 CI, two.7-9.2]; P0.001) in the week-32 assessment.The Journal of Headache and Discomfort 2017, 18(Suppl 1):Page 26 ofAEs have been reported by 45.5 of onabotulinumtoxinA and 76.eight of topiramate sufferers; critical AEs by 1.4 and four.two , respectively. Only sinusitis was reported in five of 220 patients getting onabotulinumtoxinA at any time; a variety of person AEs were reported in five receiving topiramate (Table 1). Treatment-related AEs had been reported by 17.three of onabotulinumtoxinA and 69.0 of topiramate individuals. One particular significant AE (nephrolithiasis) was reported as associated to topiramate. Conclusions In this open-label study, preventive remedy of adults with CM with onabotulinumtoxinA demonstrated a additional favorable tolerability profile than topiramate. When employing imputation methods accounting for variations in discontinuation rates, onabotulinumtoxinA was additional efficient than topiramate according to 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.