A placebo controlled, randomized, double-blind study to assess the safety and clinical benefit of rasagiline as an add-on therapy to dopamine agonist monotherapy in early Parkinson's disease (PD): The ANDANTE study

The objective of this study is to determine the efficacy and safety of rasagiline add-on therapy for early-PD patients sub-optimally controlled by dopamine agonist (DA) monotherapy. DAs are often used as initial symptomatic therapy for early-PD. With disease progression, DA monotherapy can become suboptimal, requiring increasing dose to maintain efficacy. ANDANTE is a Phase- IV, 18-week study of PD patients (Hoehn & Yahr 1-3) aged $30 years taking stable DA dosages of $6 mg/day ropinirole or $1.0 mg/day pramipexole with suboptimal symptom control. Patients were randomized to rasagiline 1mg or placebo; DA dosage remained stable throughout. Primary outcome: change from baseline in total-UPDRS score. Secondary outcomes: changes from baseline in UPDRS activities of daily living (ADL) and motor scores, and CGI-I. Safety was assessed by AE frequency and severity, and discontinuation due to Aes. Addition of rasagiline significantly improved motor symptoms in patients sub-optimally controlled with DA monotherapy, and was safe and well-tolerated with an AE profile similar to placebo.