Parkinson's Disease
Conditions
Keywords
Parkinson's disease, end-of -dose wearing-off, entacapone
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off. This study is not recruiting patients in the United States.
Detailed description
The purpose of this study is to evaluate the safety and efficacy of the long-term treatment of entacapone in patients with Parkinson's disease with end-of-dose wearing-off.
Interventions
DRUGEntacapone
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Attended the Phase IIb study * Able to fill out the patient diary
Exclusion criteria
* Serious heart, pulmonary, renal, hepatic or gastrointestinal disease * Dementia symptoms * Pregnant or nursing (lactating) women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events during the long term treatment (maximum 3 years) | — |
| Blood pressure at every 12 weeks | — |
| Laboratory test at every 16 weeks | — |
| ECG at every 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| On time based on patient diary (up to 104 weeks) | — |
| UPDRS score at every 16 weeks | — |
Countries
United States
Outcome results
None listed