Trial reportPharmaceutical research2007
Levodopa slows progression of Parkinson's disease: external validation by clinical trial simulation.
Trial report in Pharmaceutical research, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.
- Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.British journal of clinical pharmacology · 2020Pooled it
- Dose-Response Analysis of the Effect of Carbidopa-Levodopa Extended-Release Capsules (IPX066) in Levodopa-Naive Patients With Parkinson Disease.Journal of clinical pharmacology · 2016Trial
- A Markov model of fibrosis development in nonalcoholic fatty liver disease predicts fibrosis progression in clinical cohorts.CPT: pharmacometrics & systems pharmacology · 2023Article
- Developing and validating Parkinson's disease subtypes and their motor and cognitive progression.Journal of neurology, neurosurgery, and psychiatry · 2018Article
- Receiver Operating Characteristic Analysis and Clinical Trial Simulation to Inform Dose Titration Decisions.CPT: pharmacometrics & systems pharmacology · 2018Article
- Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014).CPT: pharmacometrics & systems pharmacology · 2017Article
- A review of disease progression models of Parkinson's disease and applications in clinical trials.Movement disorders : official journal of the Movement Disorder Society · 2016Review
- The Natural Progression of Parkinson's Disease in a Small Cohort with 15 Drug-naïve Patients.Chinese medical journal · 2015Article
- Review
- Disease progression and neuroscience.Journal of pharmacokinetics and pharmacodynamics · 2013Review
- Modeling and simulation to optimize the design and analysis of confirmatory trials, characterize risk-benefit, and support label claims.CPT: pharmacometrics & systems pharmacology · 2013Article
- Progression of motor and nonmotor features of Parkinson's disease and their response to treatment.British journal of clinical pharmacology · 2012Article
- Medical management of Parkinson's disease: focus on neuroprotection.Current neuropharmacology · 2011Article
- Article
- Targeting the progression of Parkinson's disease.Current neuropharmacology · 2009Article
- Protection against Parkinson's disease progression: clinical experience.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2008Review
- Disease progression, drug action and Parkinson's disease: why time cannot be ignored.European journal of clinical pharmacology · 2008Article
- Progression of MDS-UPDRS Scores Over Five Years in De Novo Parkinson Disease from the Parkinson's Progression Markers Initiative Cohort.Movement disorders clinical practiceArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo externally validate the model predictions of a DATATOP cohort analysis through application of clinical trial simulation with the study design of the ELLDOPA trial.
methodsThe stochastic pharmacokinetic-pharmacodynamic and disease progress model was developed from the large DATATOP cohort of patients followed for 8 years. ELLDOPA was designed to detect a difference between placebo and levodopa treated arms in the total Unified Parkinson's Disease Rating Scale (UPDRS) taken at baseline and following 2 weeks levodopa washout after 40 weeks of treatment. The total UPDRS response was simulated with different assumptions on levodopa effect (symptomatic with/without disease modifying capability) and washout speed of symptomatic effect.
resultsThe observed results of ELLDOPA were similar to the model predictions assuming levodopa slows disease progression and has a slow washout of symptomatic effect.
conclusionsThis simulation work confirmed the conclusion of the DATATOP analysis finding that levodopa slows disease progression. The simulation results also showed that a dose-related increased rate of progression in Parkinson's disease, obscured by symptomatic benefit, is very unlikely. Finally, the simulation results also shown that 2 weeks washout period was not adequate to completely eliminate the symptomatic benefits of levodopa.
Indexed as
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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.