Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non‐motor symptoms – results of a double‐blind, randomized, placebo‐controlled trial

Jun 23, 2015European journal of neurology

Rotigotine skin patch effects on non-movement symptoms in Parkinson's disease patients from a controlled clinical trial

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Abstract

The NMSS total score decreased by 23 points with rotigotine compared to a 19-point decrease with placebo.

The treatment difference in NMSS total score was not statistically significant, with a difference of -3.58.
Improvements were numerically greater than placebo in the 'mood/apathy' and 'miscellaneous' domains of the NMSS.
Rotigotine treatment showed significant improvements in motor symptoms measured by the Unified Parkinson's Disease Rating Scale (UPDRS III).
Patients receiving rotigotine also reported better scores on the Parkinson's Disease Questionnaire (PDQ-39) compared to those on placebo.
Adverse events more commonly associated with rotigotine included nausea, application site reactions, somnolence, and headache.

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BACKGROUND AND PURPOSE: Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality of life. This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD.

METHODS: In this double-blind trial (NCT01300819), patients with PD and a total NMSS score ≥40 were randomized (2:1) to rotigotine or placebo, titrated over 1-7 weeks to optimal dose (≤8 mg/24 h for patients not receiving levodopa, ≤16 mg/24 h for patients receiving levodopa), maintained for 12 weeks. The primary outcome was change in NMSS total score from baseline to end of maintenance. Secondary outcomes were the nine NMSS domains, Unified Parkinson's Disease Rating Scale (UPDRS) III (motor) and the 39-item Parkinson's Disease Questionnaire (PDQ-39).

RESULTS: In total, 283/349 (81.1%) randomized patients completed the trial; 211 rotigotine and 122 placebo were included in the full analysis set. The NMSS total score decreased by 23 (rotigotine) and 19 (placebo) points; the treatment difference was not statistically significant (-3.58; 95% confidence interval -8.43, 1.26; P = 0.147). Numerically greater than placebo improvements were detected in the 'mood/apathy' and 'miscellaneous' NMSS domains (P < 0.05). Treatment differences in UPDRS III (-2.60; -4.27, -0.92; P = 0.002) and PDQ-39 (-2.79; -5.21, -0.37; P = 0.024) favoured rotigotine. Adverse events reported more frequently with rotigotine were nausea, application site reactions, somnolence and headache.

CONCLUSIONS: Rotigotine improvement in the multi-domain NMSS total score was not superior to placebo. A different sensitivity of individual NMSS domains to dopaminergic therapy and a large placebo effect may have contributed to these findings.

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Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non‐motor symptoms – results of a double‐blind, randomized, placebo‐controlled trial

Abstract

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