Abstract Details

Title Long-Term, Open-Label Safety and Tolerability Study of Once-Daily Extended-Release Oxcarbazepine (SPN-804) as Adjunctive Therapy in Patients with Refractory Partial Seizures

Topic Epilepsy

Presentation(s) P04 - (-)

Poster/Presentation
Number 211

Objective

Background BACKGROUND: The efficacy and safety of adjunctive, once-daily SPN-804 was studied in a randomized, double-blind, placebo-controlled trial of adults with refractory partial epilepsy despite up to 3 concomitant antiepilepsy drugs (AEDs). We report results of the 1-year, open-label follow-up study.

Design/Methods DESIGN/METHODS: Patients continuing treatment were blindly titrated to SPN-804 1200 mg/d over 2 weeks. Thereafter, adjustments for SPN-804 (600-2400 mg/d) and concomitant AEDs were allowed. Primary endpoints were long-term safety and tolerability; secondary was effect on percent change in partial seizure frequency/28 days (PCHT) vs double-blind results. All comparisons were descriptive.

Results RESULTS: 248/366 (67.8%) patients completed the double-blind study, and 214 (58.5%) received SPN-804 during the open-label extension (mean age: 37.4y [range: 18-67y]; female: 111 [51.9%]); of these, 179 (83.6%) completed treatment. Mean (SD) treatment duration was 356.4 (85.21) days. Median PCHT reduction was -58.95 and -26.25 relative to the end of baseline and maintenance periods of the double-blind study, respectively. Treatment-related adverse events (AEs) occurred in 69 patients (32.2%); 11 (5.1%) discontinued due to AEs. Most frequent AEs were dizziness (15.4%), headache (11.2%), diplopia (9.3%), nausea (7.5%), vomiting (6.1%), and somnolence (5.6%). Rates of AEs decreased during the open-label extension, possibly because 64.1% of patients were already exposed to SPN-804 in the double-blind study. Most AEs were mild/moderate. Serious AEs occurred in 15 (7%) patients; one death due to thromboemboli was considered unrelated to SPN-804. No clinically significant changes from baseline occurred in vital signs, electrocardiogram, or laboratory values.

Conclusions CONCLUSIONS: This 1-year, open-label follow-up showed that adjunctive SPN-804 was well tolerated and further reduced seizure frequency beyond that observed during the double-blind study. Once-daily SPN-804 may provide long-term improvement in tolerability, adherence, and seizure reduction in patients with refractory epilepsy.

Authors/Disclosures
Janet Johnson PRESENTER	No disclosure on file
Scott Brittain (Supernus Pharmaceuticals, Inc.)	No disclosure on file
	No disclosure on file
Joao O. Siffert, MD	No disclosure on file

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