PROSPER Study

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Oxtellar XR® Was Evaluated in PROSPER, a Well-Controlled Trial of Refractory Partial Seizures in Patients with Epilepsy2,3

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Study design2,3

Multinational, multicenter, double-blind, randomized, placebo-controlled, 3-arm, parallel-group, phase 3 trial of 366 adult patients having a diagnosis of epilepsy with uncontrolled partial seizures with or without secondary generalization, taking a stable regimen of 1 to 3 concomitant antiepileptic drugs (AEDs), experiencing an average of 6 partial seizures per 28 days.

Primary efficacy measure2,3

  • Median percent change from baseline in partial seizure frequency per 28 days for the 16 week treatment period

Secondary efficacy measures1,3

• Median percentage change from baseline in partial seizure frequency per 28 days during the 12 week maintenance phase
• ≥50% reduction in partial seizure frequency
• Partial-seizure-free rates during treatment phase and maintenance periods

Safety and tolerability of Oxtellar XR were continuously monitored throughout the study.1-3

Patients in Study Were Taking 1 to 3 Concomitant AEDs1,2

All patients in this study had a baseline partial seizure frequency rate of ≥6 partial seizures per 28 days, and were taking 1 to 3 concomitant AEDs. Some patients also had a vagus nerve stimulator.

Oxtellar XR PROSPER Study Patient Characteristics

Discontinuation rate due to adverse events in the phase 3 Oxtellar XR study was 30% in the 2400 mg/day treatment group, 15% in the 1200 mg/day treatment group, and 8% in the placebo group.

  • One patient in the Oxtellar XR 2400 mg/day group was taking 4 AEDs via protocol exception.1

References

  1. Data on file. Supernus Pharmaceuticals, Inc. Rockville, MD.
  2. French JA, Baroldi P, Brittain ST, Johnson JK; on behalf of PROSPER Investigators Study Group. Efficacy and safety of extended-release oxcarbazepine (Oxtellar XR™) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand. 2014;129:143-153.
  3. Oxtellar XR [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.; December 2015.