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

Antonini, Angelo; Bauer, Lars; Dohin, Elisabeth; Oertel, Wolfgang H.; Rascol, Olivier; Reichmann, Heinz; Schmid, Miriam; Singh, Pritibha; Tolosa, Eduardo; Chaudhuri, K. Ray

doi:10.1111/ene.12757

Cited by 67 publications

(57 citation statements)

References 20 publications

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“…There are validated screening tools to address NMS in PD in the clinic setting. These include the NMS Questionnaire, the NMS Scale, and part 1 (Non‐Motor Aspects of Experiences of Daily Living) of the MDS‐UPDRS . However, as the NMS of PD include a multitude of clinical systems derived from complex multineurotransmitter dysfunction involving not just the dopaminergic pathways but also cholinergic, noradrenergic, and serotonergic pathways in the brain, the use of NMS as a holistic endpoint might be a challenge.…”

Section: Discussionmentioning

confidence: 99%

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

et al. 2019

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Objective To update evidence‐based medicine recommendations for treating nonmotor symptoms in Parkinson's disease (PD). Background The International Parkinson and Movement Disorder Society Evidence‐Based Medicine Committee's recommendations for treatments of PD were first published in 2002, updated in 2011, and now updated again through December 31, 2016. Methods Level I studies testing pharmacological, surgical, or nonpharmacological interventions for the treatment of nonmotor symptoms in PD were reviewed. Criteria for inclusion and quality scoring were as previously reported. The disorders covered were a range of neuropsychiatric symptoms, autonomic dysfunction, disorders of sleep and wakefulness, pain, fatigue, impaired olfaction, and ophthalmologic dysfunction. Clinical efficacy, implications for clinical practice, and safety conclusions are reported. Results A total of 37 new studies qualified for review. There were no randomized controlled trials that met inclusion criteria for the treatment of anxiety disorders, rapid eye movement sleep behavior disorder, excessive sweating, impaired olfaction, or ophthalmologic dysfunction. We identified clinically useful or possibly useful interventions for the treatment of depression, apathy, impulse control and related disorders, dementia, psychosis, insomnia, daytime sleepiness, drooling, orthostatic hypotension, gastrointestinal dysfunction, urinary dysfunction, erectile dysfunction, fatigue, and pain. There were no clinically useful interventions identified to treat non‐dementia‐level cognitive impairment. Conclusions The evidence base for treating a range of nonmotor symptoms in PD has grown substantially in recent years. However, treatment options overall remain limited given the high prevalence and adverse impact of these disorders, so the development and testing of new treatments for nonmotor symptoms in PD remains a top priority. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

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Section: Discussionmentioning

confidence: 99%

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

et al. 2019

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“…As presented in Figure S1, 110 publications involving 24,864 participants were finally included in the present study after screening 1,154 publications according to the inclusion criteria1315161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960616263646566676869707172737475767778798081828384858687888990919293949596979899100101102103104105106107108109110111…”

Section: Resultsmentioning

confidence: 99%

Comparison for Efficacy and Tolerability among Ten Drugs for Treatment of Parkinson’s Disease: A Network Meta-Analysis

Zhuo

Zhu

Jiang³

et al. 2017

Sci Rep

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Parkinson’s disease (PD) is a long term disorder affects the central nervous system and we aim to determine the relative efficacy of the current available drugs used in PD. Firstly, we performed a systematic review in current literature and eligible studies were retrieved from online databases, relevant data were extracted. Efficacy of these medications was assessed by different Unified Parkinson’s Disease Rating Scales (UPDRS). Mean difference (MD) and odds ratio (OR) were produced by pairwise or network meta-analysis (NMA). Finally, we performed a cluster analysis for the included medications with respect to their surface under the cumulative ranking curve (SUCRA). Pairwise meta-analysis suggests that selegiline had a higher ranking in UPDRS II, UPDRS III and UPDRS total than bromocriptine and levodopa. Selegiline was more tolerable than bromocriptine (OR = 0.62, CI: 0.39 to 0.98) and pramipexole was less tolerable than levodopa (OR = 1.43, CI = 1.00 to 2.04). Results of NMA indicate that patients with levodopa, pramipexole, ropinirole and selegiline exhibited a significantly improved UPDRS III than those with lazabemide. To sum up, levodopa, selegiline, ropinirole and rotigotine were recommended for PD patients as they appeared relatively high efficacy and tolerability.

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“…The DOLORES (PD0004; ClinicalTrials.gov identifier: NCT01744496) study was originally planned as a large‐scale study. However, after study commencement, a reassessment of the environment was performed in light of (1) the results of a double‐blind, placebo‐controlled study of nonmotor symptoms in PD, which did not demonstrate a statistically significant difference between rotigotine and placebo for the primary outcome, the change in the Non‐Motor Symptoms Scale (NMSS) total score, or for the individual item of the NMSS that assesses pain (exploratory outcome); (2) recognition of the complex heterogeneity of pain in PD; (3) uncertainty in terms of whether PD‐associated pain in general or specific pain types are susceptible to dopaminergic therapy. Thus, following a protocol amendment, the DOLORES study was converted into an exploratory pilot study to collect preliminary information on the potential efficacy of rotigotine on PD‐associated chronic pain.…”

Section: Methodsmentioning

confidence: 99%

A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain

Rascol

Zesiewicz

Chaudhuri

et al. 2015

The Journal of Clinical Pharmacology

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Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed.

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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: 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.

Cited by 67 publications

References 20 publications

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

Update on treatments for nonmotor symptoms of Parkinson's disease—an evidence‐based medicine review

Comparison for Efficacy and Tolerability among Ten Drugs for Treatment of Parkinson’s Disease: A Network Meta-Analysis

A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain

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