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CompletedNCT02231294Updated Sep 4, 2014

The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease

An observational study in Parkinson Disease, sponsored by Boehringer Ingelheim. Completed. Per ClinicalTrials.gov, last updated 2014-09-04.

Sponsored by Boehringer Ingelheim · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,464
Sex
All
01

Study summary

Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions

02

Conditions studied

  • Parkinson Disease

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03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 1,464 is above the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®

Inclusion criteria

  • Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study

Exclusion criteria

Exclusion Criteria:

  • Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®
  • Patients under treatment with neuroleptics should not be observed during this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,464 participants (actual)
Patient registry
No

Groups and cohorts

  • Idiopathic Parkinson's Disease Patients

    Drug: Sifrol®

Interventions

  • DrugSifrol®
06

What researchers measure

Primary outcomes

  1. Change in Parkinson signs and symptoms by means of a 4-point rating scale

    Time frame: up to 6 weeks

  2. Occurrence of tremor (rest and postural) by means of a 4-point rating scale

    Short Parkinson's Evaluation Scale (SPES)

    Time frame: up to 6 weeks

  3. Change in severity of kinetic tremor assessed by tremor spiral test

    Time frame: up to 6 weeks

  4. Occurrence of depression by means of a 4-point SPES rating scale

    Time frame: up to 6 weeks

  5. Change in severity of depression by means of an 8-point rating scale

    Clinical Global Impression (CGI) rating scale

    Time frame: up to 6 weeks

  6. Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)

    VAS (10 cm)

    Time frame: up to 6 weeks

  7. Assessment of efficacy by investigator on a 5-point rating scale

    Time frame: after 6 weeks

Secondary outcomes

  1. Number of patients with adverse drug reactions

    Time frame: up to 6 weeks

  2. Assessment of tolerability by investigator on a 5-point scale

    Time frame: after 6 weeks

  3. Assessment of tolerability by patient on a 5-point scale

    Time frame: after 6 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02231294
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Sep 4, 2014
Start date
Jul 2000
Primary completion
Jan 2002
Last update
Sep 4, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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