scholarly journals Long-Term Safety and Maintenance of Efficacy of Levodopa-Carbidopa Intestinal Gel: An Open-Label Extension of the Double-Blind Pivotal Study in Advanced Parkinson's Disease Patients

2015 ◽  
Vol 5 (1) ◽  
pp. 165-174 ◽  
Author(s):  
John T. Slevin ◽  
Hubert H. Fernandez ◽  
Cindy Zadikoff ◽  
Coleen Hall ◽  
Susan Eaton ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Open Label ◽  
Double Blind ◽  
Advanced Parkinson’S Disease ◽  
Pivotal Study ◽  
Open Label Extension

scholarly journals Long-term safety and efficacy of opicapone in Japanese Parkinson’s patients with motor fluctuations

2021 ◽  
Author(s):  
Atsushi Takeda ◽  
Ryosuke Takahashi ◽  
Yoshio Tsuboi ◽  
Masahiro Nomoto ◽  
Tetsuya Maeda ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Adverse Events ◽  
Motor Fluctuations ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Open Label Extension ◽  
Off Time

AbstractThe double-blind part of the COMFORT-PD (COMt-inhibitor Findings from Opicapone Repeated Treatment for Parkinson’s Disease) study in Japanese levodopa-treated patients with Parkinson’s disease and motor fluctuations found that both opicapone 25 and 50 mg were significantly more effective than placebo. This 52-week open-label extension study evaluated the long-term safety and efficacy of opicapone 50 mg tablets in patients who completed the double-blind part of the COMFORT-PD study. Safety was monitored via adverse events, laboratory testing, and physical, cardiovascular and neurological examinations. Efficacy was primarily assessed by change in OFF-time. Secondary efficacy measures included: ON-time, percentage of OFF/ON-time responders, other outcomes from the double-blind part. 391/437 patients were transferred to the open-label extension period and included in the safety analysis set (full analysis set, n = 387; open-label completers, n = 316). Adverse events were frequently reported (n = 338, 86.4%), but < 50% were considered drug-related (39.9%) and few were considered serious (2.6%) or led to discontinuation (2.8%). Decreased OFF-time was consistently observed over the open-label period regardless of initial randomization. Change [LSM (SE)] in OFF-time from the open-label baseline to the last visit showed a persistent effect in patients initially randomized to opicapone 25 mg [− 0.37 (0.20) h, P = 0.0689] and opicapone 50 mg [− 0.07 (0.21) h, P = 0.6913] whereas opicapone 50 mg led to a statistically significant reduction in the previous placebo group [− 1.26 (0.19) h, P < 0.05]. Once-daily opicapone 50 mg was generally well tolerated and consistently reduced OFF-time over 52 weeks in Japanese levodopa-treated patients with motor fluctuations.Trial registration JapicCTI-153112; date of registration: December 25, 2015.

Risperidone in levodopa-induced psychosis in advanced parkinson's disease: An open-label, long-term study

1997 ◽  
Vol 12 (4) ◽  
pp. 610-612 ◽  
Author(s):  
Giuseppe Meco ◽  
Andrea Alessandri ◽  
Patrizia Giustini ◽  
Vincenzo Bonifati
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Open Label ◽  
Term Study ◽  
Advanced Parkinson’S Disease ◽  
Long Term Study

Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease

2014 ◽  
Vol 126 (1) ◽  
pp. 30-38 ◽  
Author(s):  
Clare W. Makumi ◽  
Afsaneh Asgharian ◽  
Jeffrey Ellis ◽  
Soraya Shaikh ◽  
Teri Jimenez ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Prolonged Release ◽  
Open Label ◽  
Safety Study ◽  
Once Daily ◽  
Advanced Parkinson’S Disease
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