Journal Article

Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson’s disease

Asgharnejad, Mahnaz, Bauer, Lars, Surmann, Erwin, Slawek, Jaroslaw, Hauser, Robert A, Barone, Paolo, Dohin, Elisabeth

2016

Overview

Background This multicenter, double-blind, placebo-controlled study assessed the efficacy of rotigotine transdermal patch on apathy and motor symptoms in patients with Parkinson’s disease (PD). Methods Patients with PD-associated apathy (Unified Parkinson's Disease Rating Scale [UPDRS] I item 4 [motivation] ≥2 and patient-rated Apathy Scale [AS] ≥14) were randomized 1:1:1 to “low-dose” rotigotine (≤6 mg/24 h for early PD [those not receiving levodopa] or ≤8 mg/24 h for advanced PD [those receiving levodopa]), “high-dose” rotigotine (≤8 mg/24 h for early PD or ≤16 mg/24 h for advanced PD), or placebo, and maintained at optimal/maximal dose for 12 weeks. Coprimary efficacy variables were: change from baseline to End of Maintenance in patient-rated AS and UPDRS II + III total score. Recruitment was stopped after an interim futility analysis; therefore, all p values are exploratory. Results Of 122 patients randomized, 81.1 % completed the study (placebo, n = 32/40 [80.0 %]; low-dose rotigotine, n = 30/41 [73.2 %]; high-dose rotigotine, n = 37/41 [90.2 %]). No treatment difference was observed in the change in patient-rated AS (least squares mean [95 % confidence interval (CI)] difference: low-dose, 0.04 [−2.42, 2.50], p =0.977; high-dose, −0.22 [−2.61, 2.18], p = 0.859). Rotigotine improved UPDRS II + III total scores versus placebo (least squares mean [95 % CI] treatment difference: low-dose, −7.29 [−12.30, −2.28], p = 0.005; high-dose, −6.06 [−10.90, −1.21], p = 0.015), and the “mood/apathy” domain of the Non-Motor Symptom Scale as rated by the investigator (secondary outcome). The most frequent adverse events in rotigotine-treated patients were application site reactions, somnolence, and nausea. Conclusions Rotigotine did not improve PD-associated apathy as rated by the patient but provided clinically relevant improvement in motor control and activities of daily living. Trial registration ClinicalTrials.gov identifier NCT01782222 . Trial registration date: January 30, 2013.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Activities of Daily Living / Adult / Aged / Analysis / Antiparkinson Agents - administration & dosage / Apathy / Apathy - drug effects / Dopamine Agonists - administration & dosage / Dose-Response Relationship, Drug / Double-Blind Method / Female / Health aspects / Humans / Levodopa - therapeutic use / Male / Medicine / Medicine & Public Health / Middle Aged / Movement disorders / Neurochemistry / Neurology / Neurosurgery / Parkinson Disease - complications / Parkinson Disease - drug therapy / Parkinson's disease / Psychological aspects / Research Article / Tetrahydronaphthalenes - administration & dosage / Thiophenes - administration & dosage / Transdermal Patch