Journal of Neural Transmission

, Volume 120, Issue 9, pp 1321–1329

The safety and tolerability of rotigotine transdermal system over a 6-year period in patients with early-stage Parkinson’s disease

Neurology and Preclinical Neurological Studies - Original Article

DOI: 10.1007/s00702-013-1001-5

Cite this article as:
Giladi, N., Boroojerdi, B. & Surmann, E. J Neural Transm (2013) 120: 1321. doi:10.1007/s00702-013-1001-5


This open-label extension (SP716; NCT00599196) of a 6-month, double-blind, randomized study (SP513) investigated the safety and tolerability of rotigotine transdermal system over up to ~6 years in patients with Parkinson’s disease (PD; early-stage PD at double-blind enrollment). Eligible patients completing the 6-month study received optimal dose open-label rotigotine (≤16 mg/24 h) for up to ~6 years. Adjunctive levodopa was permitted. Primary outcomes included adverse events (AEs) and extent of rotigotine exposure. Analysis of adjunctive levodopa use, dyskinesias [unified Parkinson’s disease rating scale (UPDRS) IV], and efficacy (UPDRS II + III total score) were also assessed. Of 381 patients enrolled in the open-label extension, 52 % were still in the study at time of closure; 24 % withdrew because of AEs and 6 % because of lack of efficacy. Patients received rotigotine for a median duration of 1,564.5 days (~4 years, 3 months; range 5–2, 145 days). 69 % of patients started supplemental levodopa; median time to levodopa was 485 days (~1 year, 4 months). Most common AEs (% per patient-year) were somnolence (18 %), application site reactions (12 %), nausea (9 %), peripheral edema (7 %), and fall (7 %). AEs indicative of impulsive–compulsive behavior were recorded in 25 (7 %) patients. Dyskinesias were experienced by 65 (17 %) patients; the majority [47 of 65 (72 %)] reported first dyskinesia after starting levodopa. Mean UPDRS II + III total scores remained below double-blind baseline for 4 years (assessment of all patients). In conclusion, rotigotine was generally well tolerated for up to ~6 years in patients with early-stage PD. The AEs reported were in line with previous studies of rotigotine transdermal system, with typical dopaminergic side effects and application site reactions seen.


Parkinson’s diseaseLong-termSafetyRotigotine transdermal systemLevodopaDyskinesia

Copyright information

© Springer-Verlag Wien 2013

Authors and Affiliations

  1. 1.Movement Disorders Unit, Department of Neurology, Tel-Aviv Sourasky Medical Center, Sackler School of MedicineTel-Aviv UniversityTel-AvivIsrael
  2. 2.UCB PharmaRaleighUSA
  3. 3.UCB PharmaMonheimGermany