Randomized, double-blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease

• Published in: Movement disorders Vol. 25; no. 15; pp. 2542 - 2549
• Main Authors: Hauser, Robert A., Schapira, Anthony H.V., Rascol, Olivier, Barone, Paolo, Mizuno, Yoshikuni, Salin, Laurence, Haaksma, Monika, Juhel, Nolwenn, Poewe, Werner
• Format: Journal Article
• Language: English
• Published: Hoboken Wiley Subscription Services, Inc., A Wiley Company 15.11.2010; Wiley; Wiley Subscription Services, Inc
• Subjects: Aged; Antiparkinson Agents - administration & dosage; Antiparkinson Agents - adverse effects; Antiparkinson Agents - therapeutic use; Benzothiazoles - administration & dosage; Benzothiazoles - adverse effects; Benzothiazoles - therapeutic use; Biological and medical sciences; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Delayed-Action Preparations - therapeutic use; dopamine agonist; Double-Blind Method; Drug Administration Schedule; Female; Humans; Levodopa - therapeutic use; Male; Medical sciences; Middle Aged; Movement disorders; Neurology; Parkinson Disease - drug therapy; Parkinson's disease; Patient Satisfaction; pramipexole extended release; Quality of Life; Severity of Illness Index; treatment; Treatment Outcome; Evaluation; Nervous system diseases; Parkinson's disease; Parkinson disease; Pramipexole; Cerebral disorder; Treatment; Central nervous system disease; Dopamine agonist; pramipexole extended release; Degenerative disease; Release; Extrapyramidal syndrome
• ISSN: 0885-3185; 1531-8257; 1531-8257
• DOI: 10.1002/mds.23317

The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (P = 0.0282), and −8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (P = 0.0010), and −7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society