Drug Interaction With Genes in Parkinson's Disease

Parkinson's Disease Clinical Trial

— DIGPD  

Official title:

Drug Interaction With Genes in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01564992
• Other study ID #: P 071240
• Status: Recruiting
• Start date: May 2009
• Est. completion date: July 2019

Study information

• Verified date: July 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jean-Christophe Corvol, MD, PhD
• Phone: +33 1 42 16 57 66
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women, age > 18.

• Parkinson Disease according to UKPDSBB criteria

• PD diagnosis < 6 years

• Informed consent

Exclusion Criteria:

• Atypical parkinsonism

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All complications of the disease or treatment		5 years