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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02248220

Enrollment

657

Registered

2014-09-25

Start date

1998-10-31

Completion date

Unknown

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

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

Interventions

DRUGPramipexole

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* NA

Design outcomes

Primary

Measure	Time frame	Description
Change in cumulative daily doses of Sifrol®	up to 8 weeks	Changes in the doses between visits are evaluated using Wilcoxon's signed rank test
Changes in cumulative daily doses of L-dopa	up to 8 weeks	Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

Secondary

Measure	Time frame	Description
Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score	Baseline, after 8 weeks	patients with SPES depression \>= 2
Change from Baseline in Tremor Impact Scale (TIS-D) total score	Baseline, after 8 weeks	—
Change from Baseline in global Parkinson's Disease (PD) symptoms	Baseline, after 8 weeks	Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor
Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score	Baseline, after 8 weeks	—
Global assessment of tolerability by investigator on a 5-point scale	after 8 weeks	—
Number of patients with adverse events	up to 8 weeks	—
Number of patients with adverse drug reactions	up to 8 weeks	—
Global assessment of efficacy by investigator on a 5-point scale	after 8 weeks	—
Change from Baseline in SPES subscales	Baseline, after 8 weeks	Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026