Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of Disease
Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
Summary
This exploratory trial will fulfill a medical data gap for the dopamine-agonist rotigotine,
as so far no data on elderly population is available.
Primary objective: To assess efficacy and safety of rotigotine in patients with late onset
Parkinson's Disease (PD), starting at age 70 or later, on motor symptoms.
Secondary objective: To assess efficacy and safety of rotigotine in patients with late onset
Parkinson's Disease (PD), starting at age 70 or later, on selected non motor symptoms : sleep
quality; depression; cognitive function.
Subjects ≥70 years, with diagnosis of Parkinson's Disease (PD) based on the presence of at
least two of three cardinal features (bradykinesia, resting tremor, rigidity), within 12
months since diagnosis and no longer than 12 months from onset to diagnosis, and for whom the
caring physician is uncertain on whether or not to start treatment.
Outcome Measurement: Percentage of Responders to treatment in motor (part III) and Activities
of daily living (ADL) (part II) components of Unified Parkinson's Disease Rating Scale
(UPDRS) at visit 4 and 6; Percentage of Responders to treatment in sleep quality in relation
to Parkinson's Disease Sleep Scale (PDSS)-2 at visit 4 and 6; Responders to treatment in mood
in relation to Geriatric Depression Scale (GDS) at visit 4 and 6.
Exploratory, randomized, double blind, placebo-controlled study: 80 patients with late onset
Parkinson's Disease (PD) are randomized in 2 parallel groups, ratio 1:1.
One group will be treated with rotigotine and one group will be treated with placebo, for 12
weeks after titration.