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


BACKGROUND
ClinicalTrials.gov identifier NCT01782222 . Trial registration date: January 30, 2013.
Parkinson's Disease and Movement Disorders Center, USF Health - Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL, USA. rhauser@health.usf.edu.
Robert A
RA
Hauser
Department of Neurological-Psychiatric Nursing, Medical University of Gdańsk and Department of Neurology, St Adalbert Hospital, Gdańsk, Poland.
Jaroslaw
J
Slawek
Neurodegenerative Disease Center, University of Salerno, Salerno, Italy.
Paolo
P
Barone
UCB Pharma, Brussels, Belgium.
Elisabeth
E
Dohin
UCB Pharma, Monheim am Rhein, Germany.
Erwin
E
Surmann
UCB Pharma, Raleigh, NC, USA.
Mahnaz
M
Asgharnejad
UCB Pharma, Monheim am Rhein, Germany.
Lars
L
Bauer
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage*; D057565:Apathy / Q000187:drug effects*; D018491:Dopamine Agonists / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000150:complications / Q000188:drug therapy*; D013764:Tetrahydronaphthalenes / Q000008:administration & dosage*; D013876:Thiophenes / Q000008:administration & dosage*; D057968:Transdermal Patch
D000978:Antiparkinson Agents; D018491:Dopamine Agonists; D013764:Tetrahydronaphthalenes; D013876:Thiophenes; D007980:Levodopa; C047508:rotigotine
Apathy; Parkinson’s disease; Rotigotine transdermal patch; Treatment