This is a randomized, parallel group, multicentre, multinational, prospective, open-label exploratory study in Parkinson's disease (PD) patients to evaluate the add-on efficacy of opicapone 50 mg or an extra dose of levodopa (L-DOPA) 100 mg as first strategy for the treatment of wearing-off.
The study consists of a one-week screening period, four weeks of open-label treatment and two weeks of post-study follow-up. The total study duration for each patient will be approximately 7 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
50 mg hard capsules. Oral administration, once-daily at bedtime, at least 1 hour before or after L-DOPA/carbidopa or benserazide (L-DOPA/DDCI).
L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration
Change in Absolute OFF-time from baseline to end of study
OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Time frame: up to 7 weeks
Proportion of patients with one hour or more reduction in Absolute OFF-time from baseline to end of study (OFF-time responders)
OFF = Time when medication has worn off and is no longer providing benefit with regard to mobility, slowness, and stiffness.
Time frame: up to 7 weeks
Change in Absolute ON-time from baseline to end of study
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
Time frame: up to 7 weeks
Proportion of patients with one hour or more increase in Absolute ON-time from baseline to end of study (ON-time responders)
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
Time frame: up to 7 weeks
Change in Percentage OFF-time between baseline and end of study
OFF = Time when medication has worn off and is no longer providing benefit with regard
Time frame: up to 7 weeks
Change in Percentage ON-time between baseline and end of study
ON = Time when medication is providing benefit with regard to mobility, slowness, and stiffness.
Time frame: up to 7 weeks
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Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Parkinson-Klinik Ortenau GmbH&Co KG
Wolfach, Baden-Wurttemberg, Germany
Klinik Haag i. OB
Haag in Oberbayern, Bavaria, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, Germany
Praxis Dr. Oehlwein
Gera, Thuringia, Germany
Asklepios Fachklinikum Stadtroda
Stadtroda, Thuringia, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
Berlin, Germany
Praxis Dr. med. Kirsten Hahn
Berlin, Germany
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Napoli, Italy
...and 15 more locations