Severity and burden of partial-onset seizures in a phase III trial of eslicarbazepine acetate.

Abstract

OBJECTIVE:

The objective of this study was to compare posttreatment seizure severity in a phase III clinical trial of eslicarbazepine acetate (ESL) as adjunctive treatment of refractory partial-onset seizures.

METHODS:

The Seizure Severity Questionnaire (SSQ) was administered at baseline and posttreatment. The SSQ total score (TS) and component scores (frequency and helpfulness of warning signs before seizures [BS]; severity and bothersomeness of ictal movement and altered consciousness during seizures [DS]; cognitive, emotional, and physical aspects of postictal recovery after seizures [AS]; and overall severity and bothersomeness [SB]) were calculated for the per-protocol population. Analysis of covariance, adjusted for baseline scores, estimated differences in posttreatment least square means between treatment arms.

RESULTS:

Out of 547 per-protocol patients, 441 had valid SSQ TS both at baseline and posttreatment. Mean posttreatment TS for ESL 1200 mg/day was significantly lower than that for placebo (2.68 vs 3.20, p<0.001), exceeding the minimal clinically important difference (MCID: 0.48). Mean DS, AS, and SB were also significantly lower with ESL 1200 mg/day; differences in AS and SB exceeded the MCIDs. The TS, DS, AS, and SB were lower for ESL 800 mg/day than for placebo; only SB was significant (p=0.013). For both ESL arms combined versus placebo, mean scores differed significantly for TS (p=0.006), DS (p=0.031), and SB (p=0.001).

CONCLUSIONS:

Therapeutic ESL doses led to clinically meaningful, dose-dependent reductions in seizure severity, as measured by SSQ scores.

CLASSIFICATION OF EVIDENCE:

This study presents Class I evidence that adjunctive ESL (800 and 1200 mg/day) led to clinically meaningful, dose-dependent seizure severity reductions, measured by the SSQ.

• Authors: Joyce A Cramer, Fulton F Velez, Kathryn P Anastassopoulos, T Christopher Bond, Frank G Gilliam, Philippe Ryvlin, Luigi M Specchio, Xuezhe Wang, David Blum, Joana Moreira, Francisco Rocha
• Journal: Epilepsy & behavior : E&B (Epilepsy Behav) Vol. 53 Pg. 149-53 (Dec 2015) ISSN: 1525-5069 [Electronic] United States
• PMID: 26575256 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Inc. All rights reserved.

Chemical References

• Anticonvulsants
• Dibenzazepines
• eslicarbazepine acetate

Topics

• Adult
• Aged
• Anticonvulsants (therapeutic use)
• Cost of Illness
• Dibenzazepines (therapeutic use)
• Double-Blind Method
• Epilepsies, Partial (diagnosis, drug therapy)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Seizures (diagnosis, drug therapy)
• Severity of Illness Index
• Surveys and Questionnaires