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Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial.
Eur J Neurol. 2015 Oct; 22(10):1400-7.EJ

Abstract

BACKGROUND AND PURPOSE

Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality of life. This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD.

METHODS

In this double-blind trial (NCT01300819), patients with PD and a total NMSS score ≥40 were randomized (2:1) to rotigotine or placebo, titrated over 1-7 weeks to optimal dose (≤8 mg/24 h for patients not receiving levodopa, ≤16 mg/24 h for patients receiving levodopa), maintained for 12 weeks. The primary outcome was change in NMSS total score from baseline to end of maintenance. Secondary outcomes were the nine NMSS domains, Unified Parkinson's Disease Rating Scale (UPDRS) III (motor) and the 39-item Parkinson's Disease Questionnaire (PDQ-39).

RESULTS

In total, 283/349 (81.1%) randomized patients completed the trial; 211 rotigotine and 122 placebo were included in the full analysis set. The NMSS total score decreased by 23 (rotigotine) and 19 (placebo) points; the treatment difference was not statistically significant (-3.58; 95% confidence interval -8.43, 1.26; P = 0.147). Numerically greater than placebo improvements were detected in the 'mood/apathy' and 'miscellaneous' NMSS domains (P < 0.05). Treatment differences in UPDRS III (-2.60; -4.27, -0.92; P = 0.002) and PDQ-39 (-2.79; -5.21, -0.37; P = 0.024) favoured rotigotine. Adverse events reported more frequently with rotigotine were nausea, application site reactions, somnolence and headache.

CONCLUSIONS

Rotigotine improvement in the multi-domain NMSS total score was not superior to placebo. A different sensitivity of individual NMSS domains to dopaminergic therapy and a large placebo effect may have contributed to these findings.

Authors+Show Affiliations

Parkinson and Movement Disorders Unit, IRCCS Hospital San Camillo, Venice, Italy.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Paris, France.Department of Neurology, Philipps University, Marburg, Germany.Clinical Investigation Centre CIC1436, and Departments of Clinical Pharmacology and Neurosciences, INSERM and Toulouse University Hospital, Toulouse, France.Department of Neurology, University of Dresden, Dresden, Germany.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Monheim am Rhein, Germany.Neurology Service, Hospital Clinic de Barcelona, Universitat de Barcelona, IDIBAPS, Centro de Investigacion Biomedica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Barcelona Catalonia, Spain.National Parkinson Foundation International Centre of Excellence, King's College Hospital, Kings College and Kings Health Partners, London, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26095948

Citation

Antonini, A, et al. "Effects of Rotigotine Transdermal Patch in Patients With Parkinson's Disease Presenting With Non-motor Symptoms - Results of a Double-blind, Randomized, Placebo-controlled Trial." European Journal of Neurology, vol. 22, no. 10, 2015, pp. 1400-7.
Antonini A, Bauer L, Dohin E, et al. Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. Eur J Neurol. 2015;22(10):1400-7.
Antonini, A., Bauer, L., Dohin, E., Oertel, W. H., Rascol, O., Reichmann, H., Schmid, M., Singh, P., Tolosa, E., & Chaudhuri, K. R. (2015). Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. European Journal of Neurology, 22(10), 1400-7. https://doi.org/10.1111/ene.12757
Antonini A, et al. Effects of Rotigotine Transdermal Patch in Patients With Parkinson's Disease Presenting With Non-motor Symptoms - Results of a Double-blind, Randomized, Placebo-controlled Trial. Eur J Neurol. 2015;22(10):1400-7. PubMed PMID: 26095948.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of rotigotine transdermal patch in patients with Parkinson's disease presenting with non-motor symptoms - results of a double-blind, randomized, placebo-controlled trial. AU - Antonini,A, AU - Bauer,L, AU - Dohin,E, AU - Oertel,W H, AU - Rascol,O, AU - Reichmann,H, AU - Schmid,M, AU - Singh,P, AU - Tolosa,E, AU - Chaudhuri,K Ray, Y1 - 2015/06/22/ PY - 2014/12/17/received PY - 2015/04/27/accepted PY - 2015/6/23/entrez PY - 2015/6/23/pubmed PY - 2016/6/2/medline KW - Parkinson's disease KW - non-motor symptoms KW - non-motor symptoms scale KW - randomized controlled trial SP - 1400 EP - 7 JF - European journal of neurology JO - Eur J Neurol VL - 22 IS - 10 N2 - BACKGROUND AND PURPOSE: Non-motor symptoms (NMS) of Parkinson's disease (PD) have a major impact on health-related quality of life. This is the first randomized controlled trial to use the NMS Scale (NMSS) as a primary outcome to assess treatment effects on NMS in PD. METHODS: In this double-blind trial (NCT01300819), patients with PD and a total NMSS score ≥40 were randomized (2:1) to rotigotine or placebo, titrated over 1-7 weeks to optimal dose (≤8 mg/24 h for patients not receiving levodopa, ≤16 mg/24 h for patients receiving levodopa), maintained for 12 weeks. The primary outcome was change in NMSS total score from baseline to end of maintenance. Secondary outcomes were the nine NMSS domains, Unified Parkinson's Disease Rating Scale (UPDRS) III (motor) and the 39-item Parkinson's Disease Questionnaire (PDQ-39). RESULTS: In total, 283/349 (81.1%) randomized patients completed the trial; 211 rotigotine and 122 placebo were included in the full analysis set. The NMSS total score decreased by 23 (rotigotine) and 19 (placebo) points; the treatment difference was not statistically significant (-3.58; 95% confidence interval -8.43, 1.26; P = 0.147). Numerically greater than placebo improvements were detected in the 'mood/apathy' and 'miscellaneous' NMSS domains (P < 0.05). Treatment differences in UPDRS III (-2.60; -4.27, -0.92; P = 0.002) and PDQ-39 (-2.79; -5.21, -0.37; P = 0.024) favoured rotigotine. Adverse events reported more frequently with rotigotine were nausea, application site reactions, somnolence and headache. CONCLUSIONS: Rotigotine improvement in the multi-domain NMSS total score was not superior to placebo. A different sensitivity of individual NMSS domains to dopaminergic therapy and a large placebo effect may have contributed to these findings. SN - 1468-1331 UR - https://www.unboundmedicine.com/medline/citation/26095948/Effects_of_rotigotine_transdermal_patch_in_patients_with_Parkinson's_disease_presenting_with_non_motor_symptoms___results_of_a_double_blind_randomized_placebo_controlled_trial_ L2 - https://doi.org/10.1111/ene.12757 DB - PRIME DP - Unbound Medicine ER -