| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
From the University of Alabama at Birmingham (R.L.W.); Baylor College of Medicine (J.J.), Houston, TX; Columbia University (C.W.), New York, NY; University of Saskatchewan (A.R.)., Saskatoon, Canada; Schwarz Pharma (B.B.), Monheim, Germany; Louisiana State University (J.R.), Baton Rouge.
Address correspondence and reprint requests to Dr Watts, Department of Neurology, University of Alabama at Birmingham, 1720 7 Ave. S., Suite SC 350A, Birmingham, AL 35233-0017; e-mail: rlwatts{at}uab.edu
Objective: This multicenter, randomized, double-blind study was performed to compare the safety and efficacy of the once-daily dopamine agonist rotigotine, in a continuous-dosing transdermal-patch formulation, vs placebo in patients with early-stage Parkinson disease (PD).
Methods: Patients were randomized to receive placebo (n = 96) or rotigotine (n = 181), starting at 2 mg/24 h (10-cm2 patch size; 4.5-mg total drug content), titrated weekly up to 6 mg/24 h (30-cm2 patch size; 13.5-mg total drug content), and then maintained for 6 months. The primary efficacy measures were 1) the change in the Unified Parkinson's Disease Rating Scale (UPDRS) scores (parts II and III) from baseline to end of treatment and 2) responder rates (patients with 
20% improvement).
Results: Patients receiving rotigotine had a mean absolute difference of 5.28 (±1.18) points lower in UPDRS subtotal scores compared with those receiving placebo (p < 0.0001). The mean change in part III motor scores was –3.50 (±7.26) (n = 177) and was the greatest contributor to UPDRS improvement. The rotigotine group had more responders (48 vs 19%; p < 0.0001). The most commonly reported adverse events were application site reactions (44% rotigotine vs 12% placebo), nausea (41 vs17%), somnolence (33 vs 20%), and dizziness (19 vs 13%), and most were mild or moderate in intensity.
Conclusions: Transdermal rotigotine, when titrated to a dosage of 6 mg/24 h, was effective for the treatment of early-stage Parkinson disease in this trial. Adverse events were similar to those found with other transdermal systems and dopamine agonists.
This article was previously published in electronic format as an Expedited E-pub at www.neuroulogy.org.
Disclosure: This study was sponsored by Schwarz Pharma, which participated in the design and conduct of the study; collection, management, and analysis of the data; and review and approval of the manuscript. Drs. Ray Watts, Cheryl Waters, and Joseph Jankovic have received research grants from Schwarz Pharma in excess of $10,000. Drs. Jayaraman Rao and Ali Rajput have not. Drs. Ray Watts, Jayaraman Rao, Joseph Jankovic, and Cheryl Waters have received honoraria from Schwarz Pharma. Dr. Rajput has not. Dr. Babak Boroojerdi is an employee of Schwarz Pharma.
Received April 24, 2006. Accepted in final form August 24, 2006.
This article has been cited by other articles:
|
|
 |
|
  J. J. Chen and R. Pahwa Pharmacologic Management of Parkinson Disease: Choice of Initial Therapy in Early Disease Journal of Pharmacy Practice, August 1, 2008; 21(4): 244 - 253. [Abstract] [PDF]
|
|
|
|
 |
|
 R. Rosenberg Notice of Redundant Publication: "Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease" (Arch Neurol. 2007;64[5]:676-682) Arch Neurol, December 1, 2007; 64(12): 1800 - 1801. [Full Text] [PDF]
|
|
|
|
|
|
J. Jankovic, R. L. Watts, W. Martin, and B. Boroojerdi Notice of Redundant Publication: "Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease" (Arch Neurol. 2007;64[5]:676-682) Reply Arch Neurol, December 1, 2007; 64(12): 1801 - 1801. [Full Text] [PDF]
|
|
|
|
 |
|
 W. Oertel, J. S. Ross, K. Eggert, and G. Adler Rationale for transdermal drug administration in Alzheimer disease Neurology, July 24, 2007; 69(4_suppl_1): S4 - S9. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 A Dopamine Agonist Patch for Early PD Journal Watch Neurology, May 22, 2007; 2007(522): 1 - 1. [Full Text]
|
|
|
|
|
|
J. Jankovic, R. L. Watts, W. Martin, B. Boroojerdi, and for the SP 512 Rotigotine Transdermal System Clini Transdermal Rotigotine: Double-blind, Placebo-Controlled Trial in Parkinson Disease Arch Neurol, May 1, 2007; 64(5): 676 - 682. [Abstract] [Full Text] [PDF]
|
|
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
