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✓ Translated by DotMD AI Clinical Council Source: Journal of neurology, neurosurgery, and psychiatry • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33109706 ↗

Phase III Randomized Trial: Clinical staging in amyotrophic lateral sclerosis: analysis of Edaravone Study 19

Original Paper Title: “Clinical staging in amyotrophic lateral sclerosis: analysis of Edaravone Study 19”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
Systematic Review
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • The King's and MiToS staging systems provided utility in assessing clinical progression in Edaravone Study 19. These findings may support the use of staging systems as end points in ALS clinical trials and to understand the timing of benefit as measured by these scales.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of neurology, neurosurgery, and psychiatry (Multi-cohort synthesis).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of neurology, neurosurgery, and psychiatry (2021), this phase iii randomized trial evaluating human clinical outcomes investigated: This was a post hoc analysis of the Edaravone Phase III Study MCI186-19 ('Study 19') to examine the utility of clinical staging systems as end points in clinical trials in amyotrophic lateral sclerosis (ALS). Key clinical takeaway: The King's and MiToS staging systems provided utility in assessing clinical progression in Edaravone Study 19. These findings may support the use of staging systems as end points in ALS clinical trials and to understand the timing of benefit as measured by these scales.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Journal of neurology, neurosurgery, and psychiatry, 2021-02-15; Phase III Randomized Trial; Rigor 88/100): The King's and MiToS staging systems provided utility in assessing clinical progression in Edaravone Study 19. These findings may support the use of staging systems as end points in ALS clinical trials and to understand the timing of benefit as measured by these scales.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

Related DotMD Clinical Hubs & Price Ledgers

Rx: edaravone → Condition: cellular-longevity-healthspan → Condition: diagnostic-imaging →
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