Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinson's disease: Clinical trials, pharmacology and treatment
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: A multicenter phase III study (SP1037; NCT01646255) to investigate the efficacy and safety of rotigotine in Chinese patients with advanced Parkinson’s disease (PD).
Background: In three placebo-controlled studies (CLEOPATRA-PD [NCT00244387], PREFER, SP921 [NCT00522379]) rotigotine (≤16mg/24h) was efficacious and well tolerated in patients with advanced PD inadequately controlled on levodopa; majority of patients in these studies were Caucasian. Rotigotine significantly decreased time spent “off” vs placebo, and resulted in a significantly greater number of Responders (≥30% decrease in “off” time). The efficacy and safety of rotigotine in Chinese patients with advanced PD is not known.
Methods: Chinese patients with PD, inadequately controlled on levodopa (stable dose ≥200mg/day), ≥2.5h daily “off” time, Hoehn & Yahr 2-4, were randomized 1:1 to transdermally delivered rotigotine or placebo, titrated over 4 weeks, maintained at optimal/maximum dose for 12 weeks (4-16mg/24h). Primary efficacy variable: mean change in absolute time spent “off” (by patient diaries) from baseline to end of maintenance. Safety outcomes included adverse events (AEs) and discontinuations due to AEs.
Results: Of 346 patients randomized, 311 (89.9%) completed the study (151/172 [87.8%] placebo; 160/174 [92.0%] rotigotine). All patients were Chinese (203 [58.7%] male; mean [±SD] age: 62.2 [8.9] years; mean [±SD] time since PD diagnosis: 6.62 [3.70] years). Rotigotine significantly reduced absolute daily “off” time vs placebo (p=0.0002; Table 1), and resulted in a greater number of Responders (≥30% decrease in “off” time [secondary variable]): 62/168 (36.9%) placebo, 83/170 (48.8%) rotigotine; p=0.0269. Other secondary variables also showed improvement (Table 1). 86 (50.0%) placebo and 103 (59.2%) rotigotine patients reported AEs; 15 (4.3%) discontinued due to AEs (placebo: 7 [4.1%]; rotigotine: 8 [4.6%]). The most common AEs are reported in Table 2. Few reported application and instillation site reactions (MedDRA high level term): 1 (0.6%) placebo, 2 (1.1%) rotigotine.
Conclusions: Rotigotine was efficacious in Chinese patients with advanced PD, resulting in a significant reduction in “off” time vs placebo; this was of a similar magnitude to that observed in Caucasian patients. Rotigotine was generally well tolerated and the AE profile was similar to previous studies. Study funding: UCB Pharma, Shanghai, People’s Republic of China.
| Full analysis set, last observation carried forward | Mean (±SD) baseline score | Mean (±SD) change from baseline to EoM | ||||
| Placebo (n=168) | Rotigotine (n=170) | Placebo (n=168) | Rotigotine (n=170) | LS mean [95% CI] treatment difference vs placebo | P-value (ANCOVA treatment difference)* | |
| Absolute time spent “off”, hours | 6.84 (2.37) | 6.93 (2.71) | -1.13 (3.20) | -2.36 (2.83) | -1.20 [-1.83, -0.57] | 0.0002 |
| Absolute time spent “on”, hours | 8.81 (2.35) | 8.90 (2.71) | 0.94 (3.08) | 2.05 (2.98) | 1.13 [0.50, 1.77] | 0.0005 |
| Absolute time spent “on” without troublesome dyskinesia, hours | 7.95 (2.89) | 7.97 (3.25) | 1.02 (3.12) (n=147) | 2.23 (3.08) (n=158) | 1.21 [0.52, 1.89] | 0.0006 |
| Absolute time spent “on” with troublesome dyskinesia, hours | 0.86 (2.12) | 0.93 (2.33) | 0.10 (2.40) (n=147) | -0.12 (1.62) (n=158) | -0.21 [-0.64, 0.22] | 0.3346 |
| Number of "off" periods | 3.52 (1.29) | 3.32 (1.12) | -0.61 (1.59) | -0.89 (1.32) | -0.38 [-0.67, -0.09] | 0.0101 |
| Percentage of days patients woke “off” | 68.47 (40.47) | 71.14 (38.67) | -10.34 (47.81) | -21.14 (48.49) | -9.41 [-18.73, -0.10] | 0.0476 |
| Percentage of days patients woke “on” without troublesome dyskinesia | 25.62 (37.90) | 22.16 (35.19) | 7.92 (43.29) | 22.55 (45.41) | 13.15 [4.31, 21.99] | 0.0037 |
| UPDRS III (motor) | 31.7 (12.7) | 32.5 (13.6) | -3.6 (9.8) | -10.4 (10.4) | -6.57 [-8.52, -4.63] | <0.0001 |
| Preferred term* | Placebo (n=172) n (%) | Rotigotine (n=174) n (%) |
| Dizziness | 7 (4.1) | 19 (10.9) |
| Nausea | 2 (1.2) | 16 (9.2) |
| Pruritus | 10 (5.8) | 14 (8.0) |
| Dyskinesia | 7 (4.1) | 11 (6.3) |
To cite this abstract in AMA style:
Z. Zhang, M. Asgharnejad, H. Xue, E. Surmann, L. Bauer. Rotigotine transdermal patch in Chinese patients with advanced Parkinson’s disease: A randomized, double-blind study [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/rotigotine-transdermal-patch-in-chinese-patients-with-advanced-parkinsons-disease-a-randomized-double-blind-study/. Accessed November 21, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/rotigotine-transdermal-patch-in-chinese-patients-with-advanced-parkinsons-disease-a-randomized-double-blind-study/