Drug Interaction With Genes in Parkinson's Disease

• Conditions: Parkinson's Disease
• Interventions: Other: Identification of genes

• Registration Number: NCT01564992
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

This observational study aims at identifying gene modifiers of Parkinson Disease (PD) and of treatment response and adverse events of antiparkinsonian drugs. Six hundred PD patients will be followed annually for up to 5 years. A biological collection will be associated with a full clinical assessment of motor and non motor symptoms, medical and treatment history, environmental factors. The association between candidate gene polymorphisms and disease or treatment complications will be analyzed.

Detailed Description

Title : Drug interaction with genes in Parkinson Disease

Objective:

To identify genes associated to disease and treatment complication and response.

Number of subjects: 500

Study duration : 6 years

Design:

Prospective cohort with biological collection

Primary objective:

Identification of genes which polymorphism or haplotype is associated with a complication of Parkinson disease, directly or with the interaction of treatment.

Secondary objectives:

* Prevalence and incidence of disease or treatment complications

* Clinical risk factor for disease or treatment complications

* Biomarkers of disease progression, disease or treatment complications

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Status Verified: 2018-07
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13
• Primary Completion: 2019-06
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• Men and women, age > 18.
• Parkinson Disease according to UKPDSBB criteria
• PD diagnosis < 6 years
• Informed consent

Exclusion Criteria

• Atypical parkinsonism

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson disease	Identification of genes	Identification of genes

Primary Outcome Measures

Name	Time	Method
All complications of the disease or treatment	5 years

Trial Locations

Locations (1)

Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière; 🇫🇷 Paris, France