At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,089 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
In Brief
An observational study for Parkinson Disease. Completed, enrolled 1,089 participants across 238 sites.
Detailed Summary
The primary objective of this investigation is to conduct a 12-week prospective survey in PD patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy. i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesJapan
Collaborators--
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedFeb 2008
Primary CompletionAug 2009
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartJan 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 18.4 years ago