CompletedNCT01519856PIR-008/KUpdated Jan 29, 2016

PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy

An observational study in Parkinson's Disease, sponsored by Desitin Arzneimittel GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by Desitin Arzneimittel GmbH · Observational

Study type: Observational
Time perspective: Prospective
Enrollment: 908
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Parkinson's Disease

Browse trials for

Parkinson Disease 4,583

Keywords

open
non-intervention
observational

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 908 is above the median of 97 across 1,081 observational studies indexed under Parkinson Disease.

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Lead sponsor

Desitin Arzneimittel GmbH is the lead sponsor of 13 studies on the registry; none are open to participants now.

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

male and female patients with Morbus Parkinson

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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)

Exclusion criteria

Exclusion Criteria:

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

Study design

Time perspective: Prospective
Enrollment: 908 participants (actual)

Groups and cohorts

tablet
Drug: piribedil (Clarium)

Interventions

Drugpiribedil (Clarium)
oral tablets, 50 mg

What researchers measure

Primary outcomes

Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease
Time frame: 4 years

Secondary outcomes

Influence on quality of life
Time frame: 4 years
Quality of life parameters
Time frame: 4 years

Study locations

1 site

Dr. Erich Scholz
Böblingen, Baden-Wurttemberg 71034, Germany

References and documents

Publications

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. PubMed 16267842 ↗
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. PubMed 17013922 ↗
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. PubMed 15138753 ↗
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. PubMed 11903513 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01519856
Lead sponsor: Desitin Arzneimittel GmbH
Responsible party: Sponsor
First posted: Jan 27, 2012
Start date: Jun 2009
Primary completion: Dec 2014
Completion: Feb 2015
Last update: Jan 29, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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