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• W1016980274 abstract "OBJECTIVE: Evaluate efficacy, safety, and impact on quality of life (QoL) of adjunctive treatment with USL255 in adults with refractory partial-onset seizures (POS). BACKGROUND: USL255, Qudexy™ XR (topiramate) extended-release capsules, is approved for the once-daily treatment of epilepsy. USL255 demonstrated efficacy and favorable tolerability for adjunctive treatment of refractory POS in the phase 3 PREVAIL study (NCT01142193). Long-term use of USL255 was evaluated in a 1-year PREVAIL open-label extension (OLE; NCT01191086) study. DESIGN/METHODS: Patients who completed PREVAIL (N=217) were eligible to enroll in the OLE, which consisted of a 3-week blinded-conversion (to 200 mg/d USL255), 52-week open-label phase, and down titration. Changes in USL255 dosage (≤400 mg/d) and concomitant antiepileptic drugs were allowed after 11 weeks. Efficacy endpoints included median percent reduction from baseline in weekly POS frequency and 50[percnt] responder rate. Safety (treatment-emergent adverse events [TEAEs], laboratory findings, physical/neurological exams) and the Quality of Life in Epilepsy-Problems (QOLIE-31-P) and Clinical Global Impression-Change (CGI-C) scale were evaluated. Efficacy calculations used the original PREVAIL study baseline. RESULTS: Of the 210 patients who enrolled, 148 patients (70[percnt]) completed the OLE. Over the 52-week open-label phase, median percent reduction in POS frequency and 50[percnt] responder rate were 59[percnt] and 62[percnt], respectively. Incidence of treatment-related TEAEs was 49[percnt]; 9.5[percnt] of discontinuations were due to TEAEs. New individual neurocognitive/neuropsychiatric TEAEs were reported in <3[percnt] patients, except for aphasia (5.2[percnt]) and depression (3.8[percnt]). There were no abnormal trends in laboratory evaluations. At study end/early termination, 49[percnt] of patients (45/92) were rated as ‘very much’ or ‘much improved’ using CGI-C; improvements from baseline in overall QOLIE-31-P score were reported (mean change, 5.0; n=88). CONCLUSIONS: In this OLE study, treatment with ≤400 mg/d USL255 was associated with reductions in seizure frequency, functional benefits, and was safe and well-tolerated in patients with epilepsy. Study Supported by: Upsher-Smith Laboratories, Inc. Disclosure: Dr. Hogan has received personal compensation for activities with Upsher-Smith Pharmaceuticals as a consultant. Dr. Hogan has received research support from Eisai Pharmaceuticals and Upsher-Smith Pharmaceuticals. Dr. Blatt has received personal compensation for activities with Upsher-Smith Laboratories, Inc. Dr. Clark has received personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Anders has received personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Halvorsen has received personal compensation for activities with Upsher-Smith Laboratories, Inc. as an employee. Dr. Chung has received personal compensation for activities with UCB Pharma, Supermus, Esai Inc., Lundbeck Research USA, Inc., Upshire-Smith, and SK Life Science." @default.
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• W1016980274 date "2015-04-06" @default.
• W1016980274 modified "2023-09-27" @default.
• W1016980274 title "Long-Term Efficacy, Safety, and Impact on Quality of Life of USL255, Qudexy™ XR (Topiramate) Extended-Release Capsules: PREVAIL OLE (P1.247)" @default.
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