Safety of Eslicarbazepine Acetate in Elderly Subjects: A Pooled Analysis of Five Phase II Placebo-controlled Non-Epilepsy Studies (P3.240)
Bibliographic record
Abstract
OBJECTIVE: Investigate the safety of eslicarbazepine acetate (ESL) in elderly subjects who participated in non-epilepsy studies. BACKGROUND: ESL is a novel once-daily anticonvulsant, extensively converted after oral administration to eslicarbazepine, which blocks voltage-gated sodium- and calcium-channels. Phase II studies in non-epilepsy populations were conducted during the development of ESL but are not ongoing; ESL is not approved for any non-epilepsy indication. DESIGN/METHODS: Data were pooled from 5 randomized, placebo-controlled Phase II studies (BIA-2093-203/-204/-207/-209/-210) in adult subjects (蠅18 years) with bipolar disorder, postherpetic neuralgia, migraine, or fibromyalgia. Subjects received placebo or ESL (400-2400 mg/day) given once- or twice-daily. Incidence of treatment-emergent adverse events (TEAEs) was calculated in elderly subjects (蠅60 years of age) and compared with adults aged 18-59 years. RESULTS: Elderly subjects accounted for 21.4% (88/411) and 33.0% (427/1294) of placebo- and ESL-treated subjects, respectively. ESL-treated elderly subjects were exposed to a mean daily dose of 759 mg for a mean duration of 53.0 days (61.4 patient-years’ exposure). Thirty-seven (42.0%) and 243 (56.9%) of placebo- and ESL-treated elderly subjects, respectively, experienced 蠅1 TEAE. No individual TEAE occurred in 蠅10% of placebo- or ESL-treated elderly subjects. The most common TEAEs (蠅5%) in elderly subjects were dizziness (5.7% vs. 9.1% for placebo and ESL), nausea (3.4% vs. 8.9%), vertigo (3.4% vs. 7.0%), headache (4.5% vs. 6.6%), vomiting (2.3% vs. 6.3%), and fatigue (1.1% vs. 5.2%). The incidence of hyponatremia was 0% vs. 1.2%. No notable differences in the incidence of all or individual TEAEs were observed in elderly subjects compared with adults aged 18-59 years (蠅1 TEAE was experienced by 141/323 [43.7%] and 510/867 [58.8%] of placebo- and ESL-treated adults aged 18-59 years, respectively). CONCLUSIONS: The tolerability of ESL was similar in elderly and non-elderly subjects who participated in phase II non-epilepsy clinical studies. Study Supported by: Sunovion Pharmaceuticals Inc.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.017 | 0.014 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.011 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".