NCT01519856 (PIR-008/K) is a clinical trial of piribedil (Clarium) in Parkinson's Disease, sponsored by Desitin Arzneimittel GmbH.

Who is sponsoring NCT01519856?

NCT01519856 is sponsored by Desitin Arzneimittel GmbH.

What drugs are being tested in NCT01519856?

Interventions in NCT01519856: piribedil (Clarium).

What condition does NCT01519856 study?

NCT01519856 studies Parkinson's Disease.

Is NCT01519856 still recruiting?

NCT01519856 is currently completed. Last updated 28 January 2016.

Last reviewed 2016-01-28 · How we verify

NCT01519856: PIR-008/K

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function

Completed Last updated 28 January 2016

What this trial tests

trial testing piribedil (Clarium) in Parkinson's Disease in 908 participants. Completed in 1 February 2015.

Timeline

1 June 2009

Primary endpoint
1 December 2014

1 February 2015

Quick facts

Lead sponsor	Desitin Arzneimittel GmbH
Status	Completed
Study type	OBSERVATIONAL
Enrollment	908
Start date	1 June 2009
Primary completion	1 December 2014
Estimated completion	1 February 2015
Sites	1 location across Germany

Drugs / interventions tested

piribedil (Clarium) — full drug profile →

Conditions studied

Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

Desitin Arzneimittel GmbH — full company profile →

Who can join

18 and older, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
Neuro-Immune Crosstalk: Molecular Mechanisms, Biological Functions, Diseases, and Therapeutic Targets.
Guo X, Liu H, Song YJ, Wang JH, et al · · 2026 · cited 2× · PMID 41583906 · DOI 10.1002/mco2.70497

Verify or expand the search:

Other recruiting trials for Parkinson's Disease

Currently open trials in the same condition.

NCT07371338 — Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients · Phase 1 · recruiting
NCT07330258 — A US Study That Observes How Parkinson's Disease Changes Over Time in Patients Who Still Have Movement Symptoms Despite · recruiting
NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07384442 — Effects of Targeted Temporal Interference Stimulation of Cerebellar Nuclei on Tremor and Gait Disturbance in Parkinson's · NA · recruiting
NCT06562569 — Non-invasive VNS for PD Gait · NA · recruiting

Other Desitin Arzneimittel GmbH trials

Trials by the same sponsor.

NCT07393022 — Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects · Phase 1 · completed
NCT06214130 — Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets · Phase 1 · completed
NCT06211283 — Bioavailability and Food Effect of Sodium Valproate Minitablets in Healthy Subjects. · Phase 1 · completed
NCT06199791 — Single-dose, Two-way Crossover Bioequivalence of Lamotrigine in Healthy Male Volunteers Under Fasting Conditions · Phase 1 · completed
NCT05236842 — Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA) · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01519856 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Desitin Arzneimittel GmbH
Last refreshed: 28 January 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01519856.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing