ArticleEpilepsy research2020
Natural variability in seizure frequency: Implications for trials and placebo.
Article in Epilepsy research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 28 citations in OpenAlex.
- Pooled it
- Anti-seizure efficacy and retention rate of carbamazepine is highly variable in randomized controlled trials: A meta-analysis.Epilepsia open · 2022Pooled it
- Trial
- Trial
- Patterns of seizure frequency reduction in clinical trial participants with lower baseline seizure frequency.Epilepsia · 2026Article
- Article
- L-Relationship between uncertainty and average seizure frequency in clinical trials of antiseizure medications.Epilepsia · 2026Article
- Epilepsy and Placebo: A Literature Review.Neurologic clinics · 2026Review
- Inductive reasoning with large language models: A simulated randomized controlled trial for epilepsy.Epilepsy research · 2025Article
- Factors associated with placebo response rate in randomized controlled trials of antiseizure medications for focal epilepsy.Epilepsia · 2025Article
- Demonstration of Group-Level and Individual-Level Efficacy Using Time-to-Event Designs for Clinical Trials of Antiseizure Medications.Neurology · 2024Article
- Minimum clinical utility standards for wearable seizure detectors: A simulation study.Epilepsia · 2024Article
- Inductive reasoning with large language models: a simulated randomized controlled trial for epilepsy.medRxiv : the preprint server for health sciences · 2024Article
- The present and future of seizure detection, prediction, and forecasting with machine learning, including the future impact on clinical trials.Frontiers in neurology · 2024Review
- Review
- Machine Learning in Clinical Trials: A Primer with Applications to Neurology.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023Review
- Flexible realistic simulation of seizure occurrence recapitulating statistical properties of seizure diaries.Epilepsia · 2023Article
- Guidelines for Conducting Ethical Artificial Intelligence Research in Neurology: A Systematic Approach for Clinicians and Researchers.Neurology · 2021Article
- Seizure Cycles in Focal Epilepsy.JAMA neurology · 2021Article
- Epilepsy during the COVID-19 pandemic lockdown: a US population survey.Epileptic disorders : international epilepsy journal with videotape · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
Abstract
backgroundChanges in patient-reported seizure frequencies are the gold standard used to test efficacy of new treatments in randomized controlled trials (RCTs). Recent analyses of patient seizure diary data suggest that the placebo response may be attributable to natural fluctuations in seizure frequency, though the evidence is incomplete. Here we develop a data-driven statistical model and assess the impact of the model on interpretation of placebo response.
methodsA synthetic seizure diary generator matching statistical properties seen across multiple epilepsy diary datasets was constructed. The model was used to simulate the placebo arm of 5000 RCTs. A meta-analysis of 23 historical RCTs was compared to the simulations.
resultsThe placebo 50 %-responder rate (RR50) was 27.3 ± 3.6 % (simulated) and 21.1 ± 10.0 % (historical). The placebo median percent change (MPC) was 22.0 ± 6.0 % (simulated) and 16.7 ± 10.3 % (historical).
conclusionsA statistical model of daily seizure count generation which incorporates quantities related to the natural fluctuations of seizure count data produces a placebo response comparable to those seen in historical RCTs. This model may be useful in better understanding the seizure count fluctuations seen in patients in other clinical settings.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.