Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Observation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248220
• Other study ID #: 248.360
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: September 22, 2014
• Start date: October 1998

Study information

• Verified date: September 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

Assessment of daily maintenance dose of Sifrol®, L-dopa sparing effect, effect on tremor, depression, anhedonia and tolerability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 657
• Est. primary completion date: October 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with advanced idiopathic Parkinson's disease for whom combined treatment with Sifrol and L-dopa was indicated

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Pramipexole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cumulative daily doses of Sifrol®	Changes in the doses between visits are evaluated using Wilcoxon's signed rank test	up to 8 weeks	No
Primary	Changes in cumulative daily doses of L-dopa	Changes in the doses between visits are evaluated using Wilcoxon's signed rank test	up to 8 weeks	No
Secondary	Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score		Baseline, after 8 weeks	No
Secondary	Change from Baseline in SPES subscales	Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy	Baseline, after 8 weeks	No
Secondary	Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score	patients with SPES depression >= 2	Baseline, after 8 weeks	No
Secondary	Change from Baseline in Tremor Impact Scale (TIS-D) total score		Baseline, after 8 weeks	No
Secondary	Change from Baseline in global Parkinson's Disease (PD) symptoms	Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor	Baseline, after 8 weeks	No
Secondary	Global assessment of efficacy by investigator on a 5-point scale		after 8 weeks	No
Secondary	Global assessment of tolerability by investigator on a 5-point scale		after 8 weeks	No
Secondary	Number of patients with adverse events		up to 8 weeks	No
Secondary	Number of patients with adverse drug reactions		up to 8 weeks	No

External Links

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