An Update on STEADY-PD III: A Phase 3 Study of Isradipine as a Disease Modifying Agent in Patients with Early Parkinson’s Disease (P2.341)
Bibliographic record
Abstract
Objective: To evaluate the efficacy of isradipine 10 mg daily to slow progression of disability in early PD. Background: Isradipine, a dihydropyridine calcium channel antagonist, is neuroprotective in in vitro/in vivo models of parkinsonism. Epidemiological data suggests a reduced risk of PD with chronic use of dihydropyridines. Our Phase II study found isradipine 10 mg daily to be safe and well tolerated in early Parkinson's disease (PD); a dosage that achieves serum concentrations found to be neuroprotective in animal models of PD. Methods: The study is a 36 month, Phase 3, parallel group, placebo-controlled study of the efficacy of isradipine 10mg daily in 336 participants with early PD as measured by the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score. Secondary outcome measures include clinically meaningful measures of disability progression in early PD: 1) Time to initiation and utilization of dopaminergic therapy; 2) Time to onset of motor complications; 3) Change in non-motor disability. Exploratory measures include global measures of functional disability, quality of life, change in the ambulatory capacity, cognitive function and pharmacokinetic analysis. Results: The study was funded by NINDS and is being conducted at 55 Parkinson Study Group sites in US and Canada. As of October 23, 2015 335 subjects have been enrolled and there have been two premature withdrawals. The currently enrolled cohort is 69.3[percnt] male and 90.6[percnt] caucasian. Of the first 332 subjects, the mean (SD) age is 61.7 (9.6) years; total UPDRS is 26.9 (9.4); and MOCA is 28 (1.5). We anticipate enrollment to be completed by November 2015. Conclusion: This study represents a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of PD disability and provide clinically meaningful benefits. Study supported by the NINDS U01NS080818 and U01NS080840
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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 | 0.005 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.003 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.004 | 0.003 |
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".