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Article10.1212/wnl.84.14_supplement.p1.247

Long-Term Efficacy, Safety, and Impact on Quality of Life of USL255, Qudexy™ XR (Topiramate) Extended-Release Capsules: PREVAIL OLE (P1.247)

R. Edward Hogan,Ian Blatt,Annie Clark,Bob Anders,Mark Halvorsen,Steve Chung-2015-04-06-Neurology
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TL;DRAbstract

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 adve

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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 adve

Keywords

TopiramateTerm (time)Immediate releaseMedicineExtended releaseQuality of life (healthcare)PharmacologyPhysics

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