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OpenTrials
Completed

NCT Number: NCT02248220

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NA

Treatment and study plan

Pramipexole

Drug

Other names: Sifrol®

Primary outcomes

  1. Change in cumulative daily doses of Sifrol®

    Time frame: up to 8 weeks

    Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

  2. Changes in cumulative daily doses of L-dopa

    Time frame: up to 8 weeks

    Changes in the doses between visits are evaluated using Wilcoxon's signed rank test

Secondary outcomes

  1. Change from Baseline in Short Parkinson Evaluation Scale (SPES) total score

    Time frame: Baseline, after 8 weeks

  2. Change from Baseline in SPES subscales

    Time frame: Baseline, after 8 weeks

    Psychopathological disturbances, Activities of daily living, Evaluation of motor function, Tremor, Resting Tremor, Postural tremor, Complications of therapy

  3. Change from Baseline in Snaith-Hamilton-Pleasure-Scale total score

    Time frame: Baseline, after 8 weeks

    patients with SPES depression >= 2

  4. Change from Baseline in Tremor Impact Scale (TIS-D) total score

    Time frame: Baseline, after 8 weeks

  5. Change from Baseline in global Parkinson's Disease (PD) symptoms

    Time frame: Baseline, after 8 weeks

    Akinesia, anhedonia, depression, dyskinesia, motor fluctuation, cognitive disturbances, rigor and tremor

  6. Global assessment of efficacy by investigator on a 5-point scale

    Time frame: after 8 weeks

  7. Global assessment of tolerability by investigator on a 5-point scale

    Time frame: after 8 weeks

  8. Number of patients with adverse events

    Time frame: up to 8 weeks

  9. Number of patients with adverse drug reactions

    Time frame: up to 8 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1999
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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