Comparison of IPX066, a Novel Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, and CD-LD-Entacapone (CLE) in Advanced Parkinson's Disease (ASCEND-PD Trial) (S02.005)

Neurology ◽  
2012 ◽  
Vol 78 (Meeting Abstracts 1) ◽  
pp. S02.005-S02.005 ◽  
Author(s):  
F. Stocchi ◽  
U. Dillmann ◽  
A. Ellenbogen ◽  
A. Hsu ◽  
S. Khanna ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Release Formulation ◽  
Advanced Parkinson’S Disease ◽  
Extended Release Formulation

scholarly journals Pramipexole and its Extended Release Formulation for Parkinson's Disease

2011 ◽  
Vol 3 ◽  
pp. JCNSD.S5210 ◽  
Author(s):  
Paul S. Fishman
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Immediate Release ◽  
Motor Fluctuations ◽  
Release Formulation ◽  
Extended Release Formulation ◽  
Release Preparation ◽  
Early Parkinson’S Disease ◽  
Release Form

Pramipexole has been a widely used dopamine agonist for the last decade. Recently an extended release formulation of pramipexole has been introduced as both monotherapy for patients with early Parkinson's disease as well as for patients with more advanced disease, as an adjunct to L-DOPA. Along with the enhanced patient compliance seen with once a day dosing, there are other potential advantages of extended release preparations of dopamine agonists. Patients initiated on pramipexole have a lower incidence of developing motor fluctuations including dyskinesia than those initiated on L-DOPA. Pramipexole requires a prolonged dose titration compared to L-DOPA, and generally does not have the efficacy of L-DOPA. The extended release form of pramipexole shows comparable mean and peak serum levels with once a day dosing as seen with three times a day dosing of the immediate release preparation. The extended release preparation has been studied in randomized multicenter clinical trial against both placebo and the immediate release preparation in the setting of early Parkinson's disease as monotherapy and in more advanced patients with motor fluctuations on L-DOPA. In both settings the extended release preparation was superior to placebo and comparable to the immediate release form in efficacy with a similar side effect profile including nausea, sleepiness, leg edema, dyskinesias, hallucinations and impulse control disorders.

scholarly journals Pramipexole Extended Release: A Novel Treatment Option in Parkinson's Disease

2010 ◽  
Vol 2010 ◽  
pp. 1-7 ◽  
Author(s):  
Wolfram Eisenreich ◽  
Bernd Sommer ◽  
Sebastian Hartter ◽  
Wolfgang H. Jost
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Dopamine Agonist ◽  
Extended Release ◽  
Plasma Concentrations ◽  
Safety Data ◽  
Immediate Release ◽  
Efficacy And Safety ◽  
Release Formulation ◽  
Extended Release Formulation

Pramipexole, the most commonly prescribed dopamine agonist worldwide, meanwhile serves as a reference substance for evaluation of new drugs. Based on numerous clinical data and vast experiences, efficacy and safety profiles of this non-ergoline dopamine agonist are well characterized. Since October 2009, an extended-release formulation of pramipexole has been available for symptomatic treatment of Parkinson's disease. Pramipexole administration can be cut down from three times to once a day due to the newly developed extended-release formulation. This is considerable progress in regard to minimizing pill burden and enhancing compliance. Moreover, the 24 h continuous drug release of the once-daily extended-release formulation results in fewer fluctuations in plasma concentrations over time compared to immediate-release pramipexole, given three times daily. The present study summarizes pharmacokinetics and all essential pharmacological and clinical characteristics of the extended-release formulation. In addition, it provides all study data, available so far, with regard to transition and de-novo administration of extended-release formulation for patients with Parkinson's disease. It further compares efficacy and safety data of immediate-release pramipexole with the extended-release formulation of pramipexole.

scholarly journals Ropinirole Patch Versus Placebo, Ropinirole Extended‐Release Tablet in Advanced Parkinson's Disease

2020 ◽  
Vol 35 (9) ◽  
pp. 1565-1573 ◽  
Author(s):  
Nobutaka Hattori ◽  
Hideki Mochizuki ◽  
Kazuko Hasegawa ◽  
Masahiro Nomoto ◽  
Eiji Uchida ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Advanced Parkinson’S Disease ◽  
Extended Release Tablet ◽  
Release Tablet

scholarly journals Are Branded and Generic Extended-Release Ropinirole Formulations Equally Efficacious? A Rater-Blinded, Switch-Over, Multicenter Study

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Edit Bosnyák ◽  
Mihály Herceg ◽  
Endre Pál ◽  
Zsuzsanna Aschermann ◽  
József Janszky ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Extended Release ◽  
Rating Scale ◽  
Good Time ◽  
Nonmotor Symptoms ◽  
Advanced Parkinson’S Disease ◽  
Gastrointestinal Problems ◽  
Disease Rating ◽  
Structured Questionnaire

The aim of this study was to compare the efficacy of the branded and a generic extended-release ropinirole formulation in the treatment of advanced Parkinson’s disease (PD). Of 22 enrolled patients 21 completed the study. A rater blinded to treatment evaluated Unified Parkinson’s Disease Rating Scale, Fahn-Tolosa-Marin Tremor Rating Scale, Nonmotor Symptoms Assessment Scale, and a structured questionnaire on ropinirole side effects. Besides, the patients self-administered EQ-5D, Parkinson’s Disease Sleep Scale (PDSS-2), and Beck Depression Inventories. Branded and generic ropinirole treatment achieved similar scores on all tests measuring severity of motor symptoms (primary endpoint, UPDRS-III: 27.0 versus 28.0 points,P=0.505). Based on patient diaries, the lengths of “good time periods” were comparable (10.5 and 10.0 hours for branded and generic ropinirole, resp.,P=0.670). However, generic ropinirole therapy achieved almost 3.0 hours shorter on time without dyskinesia (6.5 versus. 9.5 hours,P<0.05) and 2.5 hours longer on time with slight dyskinesia (3.5 versus. 1.0 hours,P<0.05) than the branded ropinirole did. Except for gastrointestinal problems, nonmotor symptoms were similarly controlled. Patients did not prefer either formulation. Although this study has to be interpreted with limitations, it demonstrated that both generic and branded ropinirole administration can achieve similar control on most symptoms of PD.

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