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Post Hoc Analysis of Data from Two Clinical Trials Evaluating the Minimal Clinically Important Change in International Restless Legs Syndrome Sum Score in Patients with Restless Legs Syndrome (Willis-Ekbom Disease)
Minimal Important Change in Restless Legs Syndrome Severity Based on Two Clinical Trials
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Abstract
The minimal clinically important change (MCIC) total IRLS cut-off score was found to be -9 for significant improvement in patients treated with the rotigotine transdermal system.
- The MCIC cut-off score for 'much improved vs minimally improved' was -9, indicating a meaningful change in symptoms.
- For 'much improved/very much improved vs minimally improved or worse,' the MCIC cut-off score was -11, suggesting a higher threshold for significant clinical improvement.
- The MCIC score of -9 also applied for the comparison of 'minimally improved or better vs no change or worse,' reflecting consistent findings across analyses.
- Similar MCIC cut-off scores were observed in two separate studies, SP790 and SP792, reinforcing the reliability of the results.
- Receiver operating characteristic (ROC) analysis was used to establish these MCIC values based on patient-reported outcomes.
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