High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease

REKTOR, Ivan, Tomislav BABIC, Bernard BOOTHMANN, Jiří POLÍVKA, Babak BOROOJERDI and Olaf RANDERATH. High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease. Clinical Neuropharmacology. 2009, vol. 32, No 4, p. 193-198. ISSN 0362-5664. Available from: https://dx.doi.org/10.1097/WNF.0b013e31819a689f.

Basic information

• Original name: High Doses of Rotigotine Transdermal Patch: Results of an Open-Label, Dose-Escalation Trial in Patients With Advanced-Stage, Idiopathic Parkinson Disease
• Name in Czech: Vysoké dávkování ratigiotinu v transdermální náplasti.
• Authors: REKTOR, Ivan (203 Czech Republic, guarantor, belonging to the institution), Tomislav BABIC (826 United Kingdom of Great Britain and Northern Ireland), Bernard BOOTHMANN (826 United Kingdom of Great Britain and Northern Ireland), Jiří POLÍVKA (203 Czech Republic), Babak BOROOJERDI (276 Germany) and Olaf RANDERATH (276 Germany).
• Edition: Clinical Neuropharmacology, 2009, 0362-5664.

Other information

• Original language: English
• Type of outcome: Article in a journal
• Field of Study: 30000 3. Medical and Health Sciences
• Country of publisher: United States of America
• Confidentiality degree: is not subject to a state or trade secret
• Impact factor: Impact factor: 2.349
• RIV identification code: RIV/00216224:14110/09:00051287
• Organization unit: Faculty of Medicine
• Doi: http://dx.doi.org/10.1097/WNF.0b013e31819a689f
• UT WoS: 000268841600004
• Keywords (in Czech): rotigotin; transdermální náplast
• Keywords in English: dopamine agonist; dose escalation; Parkinson disease; rotigotine transdermal patch
• Tags: International impact

Abstract

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.

Links

• MSM0021622404, plan (intention): Name: Vnitřní organizace a neurobiologické mechanismy funkčních systémů CNS

Investor: Ministry of Education, Youth and Sports of the CR, The internal organisation and neurobiological mechanisms of functional CNS systems under normal and pathological conditions.