Trial reportAdvances in therapy2025
Temporal Profile of Treatment-Emergent Adverse Events in Adult Asian Patients with Focal-Onset Seizures During Adjunctive Brivaracetam Treatment: Post Hoc Analysis of a Phase 3, Randomized Trial.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03083665 (A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects), which is not on this map. Cited by 1 paper.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
Who cites it
1 citing paper in PubMed.
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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionWe assessed the time course of treatment-emergent adverse events (TEAEs) in adult Asian patients (in Thailand, Japan, China, Philippines, Malaysia, Singapore, and Taiwan) with focal-onset seizures (FOS) during adjunctive brivaracetam (BRV) treatment.
methodsPost hoc analysis of EP0083/NCT03083665, a Phase 3, randomized, double-blind, placebo (PBO)-controlled trial that evaluated BRV 50 and 200 mg/day in adult Asian patients (≥ 16-80 years) with FOS. Following an 8-week prospective baseline, patients were randomized 1:1:1 to PBO, BRV 50 mg, or BRV 200 mg and entered a 12-week treatment period.
resultsOverall, 448 patients (mean age 34.5 years; 53.8% female) received ≥ 1 dose of trial medication (PBO/BRV 50 mg/BRV 200 mg: n = 149/151/148 [Safety Set]). The overall incidence of TEAEs was similar across treatment arms (53.6-58.1%), and most TEAEs were mild in intensity (45.0-48.3%). Patients discontinuing BRV because of TEAEs (1.3% BRV 50 mg; 2.7% BRV 200 mg) discontinued during the first 5 weeks of treatment (for PBO, discontinuations due to TEAEs [3.4%] took place between weeks 1-8). The incidence of drug-related TEAEs was 18.1% in patients receiving PBO, 24.5% in those on BRV 50 mg/day, and 39.2% for BRV 200 mg/day; however, most were of mild intensity and did not lead to BRV discontinuation. The incidence of TEAEs and drug-related TEAEs was highest during the first week of adjunctive BRV treatment and decreased thereafter. The onset of drug-related somnolence and dizziness occurred mainly during the first week of treatment.
conclusionIn Asian adults with FOS, most drug-related TEAEs were mild in intensity, indicating that adjunctive BRV had a favorable tolerability profile when initiated at a potentially therapeutic dose without titration. The incidence of drug-related TEAEs including somnolence and dizziness was highest during the first week of adjunctive BRV treatment, abating thereafter. These tolerability data could help inform patient monitoring and treatment decisions when prescribing BRV.
trial registrationClinicalTrials.gov NCT03083665.
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