NCT01519856

Brief Summary

Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
908

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

July 1, 2015

Enrollment Period

5.5 years

First QC Date

March 12, 2010

Last Update Submit

January 28, 2016

Conditions

Parkinson's Disease

Keywords

opennon-interventionobservational

Outcome Measures

Primary Outcomes (1)

  • Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease

    4 years

Secondary Outcomes (2)

  • Influence on quality of life

    4 years

  • Quality of life parameters

    4 years

Study Arms (1)

tablet

Drug: piribedil (Clarium)

Interventions

piribedil (Clarium)DRUG

oral tablets, 50 mg

tablet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male and female patients with Morbus Parkinson

You may qualify if:

  • newly diagnosed or advanced idiopathic Parkinson's disease
  • male and female patients over 18 years of age
  • indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)

You may not qualify if:

  • in line with piribedil SmPC
  • in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Erich Scholz

Böblingen, Baden-Wurttemberg, 71034, Germany

Location

Related Publications (4)

  • Castro-Caldas A, Delwaide P, Jost W, Merello M, Williams A, Lamberti P, Aguilar M, Del Signore S, Cesaro P; Parkinson-Control Study Group. The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease. Mov Disord. 2006 Apr;21(4):500-9. doi: 10.1002/mds.20750.

    PMID: 16267842BACKGROUND

  • Rascol O, Dubois B, Caldas AC, Senn S, Del Signore S, Lees A; Parkinson REGAIN Study Group. Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study. Mov Disord. 2006 Dec;21(12):2110-5. doi: 10.1002/mds.21122.

    PMID: 17013922BACKGROUND

  • Peretti CS, Gierski F, Harrois S. Cognitive skill learning in healthy older adults after 2 months of double-blind treatment with piribedil. Psychopharmacology (Berl). 2004 Nov;176(2):175-81. doi: 10.1007/s00213-004-1869-8. Epub 2004 May 12.

    PMID: 15138753BACKGROUND

  • Schuck S, Bentue-Ferrer D, Kleinermans D, Reymann JM, Polard E, Gandon JM, Allain H. Psychomotor and cognitive effects of piribedil, a dopamine agonist, in young healthy volunteers. Fundam Clin Pharmacol. 2002 Feb;16(1):57-65. doi: 10.1046/j.1472-8206.2002.00070.x.

    PMID: 11903513BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

PiribedilLoratadine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesPolycyclic Compounds

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2010

First Posted

January 27, 2012

Study Start

June 1, 2009

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

January 29, 2016

Record last verified: 2015-07

Locations

DE(1)