Transdermal rotigotine in early stage Parkinson's disease: A randomized, double-blind, placebo-controlled trial

ABSTRACT Background We conducted a randomized, double‐blind, placebo‐controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan. Methods Patients received once‐daily rotigotine 2 to...

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Published in:Movement disorders 2013-09, Vol.28 (10), p.1447-1450
Main Authors: Mizuno, Yoshikuni, Nomoto, Masahiro, Kondo, Tomoyoshi, Hasegawa, Kazuko, Murata, Miho, Takeuchi, Masahiro, Ikeda, Junji, Tomida, Takayuki, Hattori, Nobutaka
Format: Article
Language:English
Subjects:
Administration, Cutaneous
Age Factors
Aged
Antiparkinson Agents - administration & dosage
Antiparkinson Agents - adverse effects
Antiparkinson Agents - therapeutic use
Disease Progression
Double-Blind Method
Drug therapy
early stage Parkinson's disease
Endpoint Determination
Female
Humans
Male
Middle Aged
Movement disorders
Parkinson Disease - drug therapy
Parkinson's disease
randomized controlled trial
rotigotine
Tetrahydronaphthalenes - administration & dosage
Tetrahydronaphthalenes - adverse effects
Tetrahydronaphthalenes - therapeutic use
Thiophenes - administration & dosage
Thiophenes - adverse effects
Thiophenes - therapeutic use
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Summary:ABSTRACT Background We conducted a randomized, double‐blind, placebo‐controlled trial to determine the safety and efficacy of transdermal rotigotine at doses up to 16 mg/24 hours in patients with early stage Parkinson's disease (PD) in Japan. Methods Patients received once‐daily rotigotine 2 to 16 mg/24 hours (mean dose, 12.8 mg/24 hours; n = 82) or placebo (n = 90) for 12 weeks. The primary endpoint was the change in Unified Parkinson's Disease Rating Scale (UPDRS) part II (activities of daily living) and part III (motor function) scores from baseline to the end of treatment. Results The mean (± standard deviation) changes in UPDRS part II and III scores were −8.4 ± 9.7 in the rotigotine group and −4.1 ± 8.2 in the placebo group and were significantly different (P = 0.002). More patients in the rotigotine group than in the placebo group had a ≥20% score reduction. No serious drug‐related adverse events were reported. Conclusions Rotigotine at doses up to 16 mg/24 hours was well tolerated and improved function in patients with early stage PD. © 2013 International Parkinson and Movement Disorder Society
ISSN:0885-3185
1531-8257
DOI:10.1002/mds.25537