Evaluation of rotigotine transdermal patch for the treatment of apathy and motor symptoms in Parkinson's disease.

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: Robert A Hauser, Jaroslaw Slawek, Paolo Barone, Elisabeth Dohin, Erwin Surmann, Mahnaz Asgharnejad, Lars Bauer
• Journal: BMC neurology (BMC Neurol) Vol. 16 Pg. 90 (Jun 07 2016) ISSN: 1471-2377 [Electronic] England
• PMID: 27267880 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antiparkinson Agents
• Dopamine Agonists
• Tetrahydronaphthalenes
• Thiophenes
• Levodopa
• rotigotine

Topics

• Activities of Daily Living
• Adult
• Aged
• Antiparkinson Agents (administration & dosage)
• Apathy (drug effects)
• Dopamine Agonists (administration & dosage)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Humans
• Levodopa (therapeutic use)
• Male
• Middle Aged
• Parkinson Disease (complications, drug therapy)
• Tetrahydronaphthalenes (administration & dosage)
• Thiophenes (administration & dosage)
• Transdermal Patch