Trial reportNeurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics2012
Lamotrigine XR conversion to monotherapy: first study using a historical control group.
Trial report in Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00355082 (A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures), which is not on this map. Cited by 21 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Multicenter, Double-Blind, Randomized Conversion to Monotherapy Comparison of Two Doses of Lamotrigine for the Treatment of Partial Seizures
Who cites it
21 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data.The Cochrane database of systematic reviews · 2022Pooled it
- Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data.The Cochrane database of systematic reviews · 2017Pooled it
- Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data.The Cochrane database of systematic reviews · 2017Pooled it
- Time to prerandomization monthly seizure count in perampanel trials: A novel epilepsy endpoint.Neurology · 2015Trial
- Trial
- Efficacy and safety of conversion to monotherapy with eslicarbazepine acetate in adults with uncontrolled partial-onset seizures: a historical-control phase III study.BMC neurology · 2015Trial
- Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study.Epilepsia · 2014Trial
- Pregabalin monotherapy in patients with partial-onset seizures: a historical-controlled trial.Neurology · 2014Trial
- Demonstration of Group-Level and Individual-Level Efficacy Using Time-to-Event Designs for Clinical Trials of Antiseizure Medications.Neurology · 2024Article
- Review
- Application of Bayesian methods to accelerate rare disease drug development: scopes and hurdles.Orphanet journal of rare diseases · 2022Review
- Ictal asystole during long-term video-EEG; semiology, localization, and intervention.Epilepsy & behavior reports · 2021Article
- From clinical trials of antiepileptic drugs to treatment.Epilepsia open · 2018Article
- Review
- Modified-Release Formulations of Second-Generation Antiepileptic Drugs: Pharmacokinetic and Clinical Aspects.CNS drugs · 2015Review
- Update on once-daily zonisamide monotherapy in partial seizures.Neuropsychiatric disease and treatment · 2014Review
- Issues related to development of new antiseizure treatments.Epilepsia · 2013Review
- Creation and implementation of a historical controls database from randomized clinical trials.Journal of the American Medical Informatics Association : JAMIA · 2013Article
- Long-term tolerability and safety of lamotrigine extended-release: pooled analysis of three clinical trials.Clinical drug investigation · 2013Article
- Antiepileptic drug selection for partial-onset seizures.Current treatment options in neurology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The efficacy and safety of lamotrigine extended-release tablets (LTG XR) as monotherapy for partial seizures were evaluated using the conversion-to-monotherapy design, and historical data as the control. This methodology was recently approved by the United States Food and Drug Administration, and this study is the first historical control design in epilepsy to complete enrollment. Patients ≥13 years old with uncontrolled partial epilepsy receiving monotherapy with valproate or a noninducing antiepileptic drug were converted to once-daily LTG XR (250 mg or 300 mg) as monotherapy and were followed up for 12 additional weeks. Efficacy was measured by the proportion of patients meeting predefined escape criteria for seizure worsening compared with aggregated pseudoplacebo control data from 8 previously conducted conversion-to-monotherapy trials. Nonoverlap of the 95% confidence limit for LTG XR and the 95% prediction interval of the historical control denotes efficacy. Of 226 randomized patients, 174 (93 in 300 mg/day group and 81 in 250 mg/day group) started withdrawal of the background AED and were evaluated for escape. In the historical control analysis population, the lower 95% prediction interval of the historical control (65.3%) was not overlapped by the upper 95% confidence limit of either LTG XR (300 mg/day; 37.2%) or LTG XR (250 mg/day; 43.4%). Adverse events were reported in 53% and 61% of patients receiving LTG XR (300 mg/day and 250 mg/day, respectively). LTG XR (250 mg or 300 mg once daily) is effective for conversion-to-monotherapy treatment of partial seizures in patients ≥13 years old.
Indexed as
Identifiers
What OpenQuestion holds
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.