High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease
| Authors | |
|---|---|
| Year of publication | 2009 |
| Type | Article in Periodical |
| Magazine / Source | Clinical Neuropharmacology |
| MU Faculty or unit | |
| Citation | |
| Doi | http://dx.doi.org/10.1097/WNF.0b013e31819a689f |
| Field | Neurology, neurosurgery, neurosciences |
| Keywords | dopamine agonist; dose escalation; Parkinson disease; rotigotine transdermal patch |
| Description | Objective: The objective of the study was to determine the maximal achievable dose of rotigotine by assessing the tolerability of escalating doses of rotigotine transdermal patch in patients with advanced-stage Parkinson disease. Methods: Thirty-four patients aged 30 years or older oil a stable dose of L-dopa with all off time of at least 2.5 h/d were randomized to 2-titration schemes. The patients started on a dosage of 4 mg/24 h and received an incremental dosage of 4 mg/24 h per week: in the fast-titration group and 2 mg/24 h per week in the slow-titration group to the maximal target dosage of 24 mg/24 h (patch size of 120 cm(2)). Thereafter, both groups entered a maintenance period of 42 days or longer for the rapid-titration group and 7 days or longer for the slow titration group followed by a 2-week safety follow-up period with stepwise dosage de-escalation of 4 mg/24 h for 4 days. Results: Twenty-seven patients completed the trial, of whom 24 completed without dose reduction. Twenty-six patients (76%) were titrated to the maximum target dose and thus had a maximal achievable dosage of at least 24 mg/24 h. Adverse events, generally mild or moderate, included application site reaction (12%), nausea, dyskinesia, and visual hallucinations (9% each). The mean time spent off decreased by 2 to 3 h/d. Duration of oil without dyskinesia periods increased (2 h/d). The mean total (SD) Unified Parkinson's Disease Rating Score decreased by 18.9 (14.2) in the fast-titration group and 17.8 (14.0) in the slow titration group. A shift from off to on without dyskinesias in status after waking up was observed. Conclusions: Rotigotine transdermal patch, Lip to 24 mg/24 It, was effective and well tolerated by patients with advanced-stage Parkinson disease. |
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