Long-term safety, efficacy, and quality of life during adjunctive brivaracetam treatment in patients with uncontrolled epilepsy: An open-label follow-up trial

Manuel Toledo, Christian Brandt, Pier Paolo Quarato, Anne-Liv Schulz, Jody M Cleveland, Gilbert Wagener, Pavel Klein

Research output: Contribution to journalArticlepeer-review

Abstract

OBJECTIVES: The primary objective of this long-term follow-up (LTFU) trial was to evaluate the long-term safety and tolerability of brivaracetam (BRV). The secondary objective was to evaluate the maintenance of efficacy of BRV (including quality of life) over time.

METHODS: This open-label, multicenter, flexible-dose trial (N01379 [NCT01339559]) was conducted in adults (≥16 years) with focal or generalized-onset seizures, who had participated in a placebo (PBO)-controlled trial of adjunctive BRV (N01258: NCT01405508 or N01358: NCT01261325).

RESULTS: Seven hundred and sixty-six patients received BRV in this LTFU trial (753 had focal seizures and 13 had generalized-onset seizures). Kaplan-Meier-estimated retention was 71.9% at 12 months, and 53.7% at 36 months. Treatment-emergent adverse events (TEAEs) were reported by 643 (83.9%) patients, most commonly headache (104 [13.6%] patients) and dizziness (100 [13.1%] patients). Two hundred and fifty-seven (33.6%) patients had drug-related TEAEs, most commonly somnolence (49 [6.4%] patients) and dizziness (41 [5.4%] patients). Permanent discontinuation of BRV due to TEAEs occurred in 91 (11.9%) patients. Patients with focal seizures had a median percentage reduction in focal seizure frequency of 52.0% and 51.7% were 50% responders (sustained over time); 26.0% were seizurefree for 6 months, and 17.9% were seizurefree for 12 months. 42.4% of patients at 12 months and 46.8% at 24 months had clinically meaningful improvements in Patient Weighted Quality of Life in Epilepsy Questionnaire 31 total score.

CONCLUSIONS: In this select group of patients who entered the LTFU trial, BRV was generally safe and well tolerated. Results indicate the long-term efficacy of BRV in patients with focal seizures.

Original languageEnglish
Pages (from-to)107897
JournalEpilepsy Behav.
Volume118
DOIs
Publication statusPublished - May 2021

Keywords

  • Adult
  • Anticonvulsants/therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Epilepsy/drug therapy
  • Follow-Up Studies
  • Humans
  • Pyrrolidinones/therapeutic use
  • Quality of Life
  • Treatment Outcome

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