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Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease.
BMC Neurol. 2016 Jun 07; 16:90.BN

Abstract

BACKGROUND

This multicenter, double-blind, placebo-controlled study assessed the efficacy of rotigotine transdermal patch on apathy and motor symptoms in patients with Parkinson's disease (PD).

METHODS

Patients with PD-associated apathy (Unified Parkinson's Disease Rating Scale [UPDRS] I item 4 [motivation] ≥2 and patient-rated Apathy Scale [AS] ≥14) were randomized 1:1:1 to "low-dose" rotigotine (≤6 mg/24 h for early PD [those not receiving levodopa] or ≤8 mg/24 h for advanced PD [those receiving levodopa]), "high-dose" rotigotine (≤8 mg/24 h for early PD or ≤16 mg/24 h for advanced PD), or placebo, and maintained at optimal/maximal dose for 12 weeks. Coprimary efficacy variables were: change from baseline to End of Maintenance in patient-rated AS and UPDRS II + III total score. Recruitment was stopped after an interim futility analysis; therefore, all p values are exploratory.

RESULTS

Of 122 patients randomized, 81.1 % completed the study (placebo, n = 32/40 [80.0 %]; low-dose rotigotine, n = 30/41 [73.2 %]; high-dose rotigotine, n = 37/41 [90.2 %]). No treatment difference was observed in the change in patient-rated AS (least squares mean [95 % confidence interval (CI)] difference: low-dose, 0.04 [-2.42, 2.50], p =0.977; high-dose, -0.22 [-2.61, 2.18], p = 0.859). Rotigotine improved UPDRS II + III total scores versus placebo (least squares mean [95 % CI] treatment difference: low-dose, -7.29 [-12.30, -2.28], p = 0.005; high-dose, -6.06 [-10.90, -1.21], p = 0.015), and the "mood/apathy" domain of the Non-Motor Symptom Scale as rated by the investigator (secondary outcome). The most frequent adverse events in rotigotine-treated patients were application site reactions, somnolence, and nausea.

CONCLUSIONS

Rotigotine did not improve PD-associated apathy as rated by the patient but provided clinically relevant improvement in motor control and activities of daily living.

TRIAL REGISTRATION

ClinicalTrials.gov identifier NCT01782222 . Trial registration date: January 30, 2013.

Authors+Show Affiliations

Parkinson's Disease and Movement Disorders Center, USF Health - Byrd Institute, National Parkinson Foundation Center of Excellence, Tampa, FL, USA. rhauser@health.usf.edu.Department of Neurological-Psychiatric Nursing, Medical University of Gdańsk and Department of Neurology, St Adalbert Hospital, Gdańsk, Poland.Neurodegenerative Disease Center, University of Salerno, Salerno, Italy.UCB Pharma, Brussels, Belgium.UCB Pharma, Monheim am Rhein, Germany.UCB Pharma, Raleigh, NC, USA.UCB Pharma, Monheim am Rhein, Germany.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27267880

Citation

Hauser, Robert A., et al. "Evaluation of Rotigotine Transdermal Patch for the Treatment of Apathy and Motor Symptoms in Parkinson's Disease." BMC Neurology, vol. 16, 2016, p. 90.
Hauser RA, Slawek J, Barone P, et al. Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease. BMC Neurol. 2016;16:90.
Hauser, R. A., Slawek, J., Barone, P., Dohin, E., Surmann, E., Asgharnejad, M., & Bauer, L. (2016). Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease. BMC Neurology, 16, 90. https://doi.org/10.1186/s12883-016-0610-7
Hauser RA, et al. Evaluation of Rotigotine Transdermal Patch for the Treatment of Apathy and Motor Symptoms in Parkinson's Disease. BMC Neurol. 2016 Jun 7;16:90. PubMed PMID: 27267880.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease. AU - Hauser,Robert A, AU - Slawek,Jaroslaw, AU - Barone,Paolo, AU - Dohin,Elisabeth, AU - Surmann,Erwin, AU - Asgharnejad,Mahnaz, AU - Bauer,Lars, Y1 - 2016/06/07/ PY - 2015/11/27/received PY - 2016/05/24/accepted PY - 2016/6/9/entrez PY - 2016/6/9/pubmed PY - 2016/12/20/medline KW - Apathy KW - Parkinson’s disease KW - Rotigotine transdermal patch KW - Treatment SP - 90 EP - 90 JF - BMC neurology JO - BMC Neurol VL - 16 N2 - BACKGROUND: This multicenter, double-blind, placebo-controlled study assessed the efficacy of rotigotine transdermal patch on apathy and motor symptoms in patients with Parkinson's disease (PD). METHODS: Patients with PD-associated apathy (Unified Parkinson's Disease Rating Scale [UPDRS] I item 4 [motivation] ≥2 and patient-rated Apathy Scale [AS] ≥14) were randomized 1:1:1 to "low-dose" rotigotine (≤6 mg/24 h for early PD [those not receiving levodopa] or ≤8 mg/24 h for advanced PD [those receiving levodopa]), "high-dose" rotigotine (≤8 mg/24 h for early PD or ≤16 mg/24 h for advanced PD), or placebo, and maintained at optimal/maximal dose for 12 weeks. Coprimary efficacy variables were: change from baseline to End of Maintenance in patient-rated AS and UPDRS II + III total score. Recruitment was stopped after an interim futility analysis; therefore, all p values are exploratory. RESULTS: Of 122 patients randomized, 81.1 % completed the study (placebo, n = 32/40 [80.0 %]; low-dose rotigotine, n = 30/41 [73.2 %]; high-dose rotigotine, n = 37/41 [90.2 %]). No treatment difference was observed in the change in patient-rated AS (least squares mean [95 % confidence interval (CI)] difference: low-dose, 0.04 [-2.42, 2.50], p =0.977; high-dose, -0.22 [-2.61, 2.18], p = 0.859). Rotigotine improved UPDRS II + III total scores versus placebo (least squares mean [95 % CI] treatment difference: low-dose, -7.29 [-12.30, -2.28], p = 0.005; high-dose, -6.06 [-10.90, -1.21], p = 0.015), and the "mood/apathy" domain of the Non-Motor Symptom Scale as rated by the investigator (secondary outcome). The most frequent adverse events in rotigotine-treated patients were application site reactions, somnolence, and nausea. CONCLUSIONS: Rotigotine did not improve PD-associated apathy as rated by the patient but provided clinically relevant improvement in motor control and activities of daily living. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01782222 . Trial registration date: January 30, 2013. SN - 1471-2377 UR - https://www.unboundmedicine.com/medline/citation/27267880/Evaluation_of_rotigotine_transdermal_patch_for_the_treatment_of_apathy_and_motor_symptoms_in_Parkinson's_disease_ L2 - https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-016-0610-7 DB - PRIME DP - Unbound Medicine ER -