Study Designs

The CLEOPATRA-PD (Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00244387","term_id":"NCT00244387"}}NCT00244387), PREFER, and SP921 (Clinicaltrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00522379","term_id":"NCT00522379"}}NCT00522379) studies were phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical studies of rotigotine in patients with advanced PD. The eligibility criteria for each of the 3 phase 3 studies have been published in detail.^12–14 Briefly, eligible patients were 30 years or older, had been diagnosed with idiopathic PD for at least 3 years, were Hoehn & Yahr stages 2 to 4, and were judged by the treating physician to be inadequately controlled on levodopa (and at a stable dose for ≥4 weeks before baseline); and to further validate their suboptimal parkinsonian control, patients needed to demonstrate an average “off” time of ≥2.5 h/d as recorded in self-reported home diaries.

In all studies, patients were receiving a stable dose of levodopa; patients were randomized to placebo (ie, received placebo + levodopa) or rotigotine (ie, received rotigotine + levodopa). In CLEOPATRA-PD, patients were titrated to an optimal rotigotine dose of 4 to 16 mg/24 h and maintained on that dose for 16 weeks.¹² In PREFER, patients were titrated to either ≤8 or ≤12 mg/24 h of rotigotine and maintained at that dose for 24 weeks.¹³ In SP921, patients were titrated to 2, 4, 6, or 8 mg/24 h of rotigotine and maintained at that dose for 12 weeks.¹⁴ Patients in all studies provided written informed consent. All studies were conducted in accordance with Good Clinical Practice and the Declaration of Helsinki. The study protocols and amendments were approved by a national, regional, or independent ethics committee or institutional review board.