Drug Interaction With Genes in Parkinson's Disease (DIGPD)

This study is currently recruiting participants. (see Contacts and Locations)

Verified May 2016 by Assistance Publique - Hôpitaux de Paris

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01564992

First received: February 23, 2012

Last updated: June 20, 2016

Last verified: May 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

February 23, 2012

Last Updated Date

June 20, 2016

Start Date ^ICMJE

May 2009

Estimated Primary Completion Date

June 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

All complications of the disease or treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01564992 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug Interaction With Genes in Parkinson's Disease

Official Title ^ICMJE

Drug Interaction With Genes in Parkinson's Disease

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

blood

Sampling Method

Non-Probability Sample

Study Population

Men and women adults with a Parkinson Disease according to UKPDSBB criteria, diagnosed < 6 years

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

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.

Other Name: polymorphism or haplotype

Study Group/Cohort (s)

Parkinson disease

Identification of genes

Intervention: Other: Identification of genes

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

600

Estimated Completion Date

July 2017

Estimated Primary Completion Date

June 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

- Atypical parkinsonism

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jean-Christophe Corvol, MD, PhD

+33 1 42 16 57 66

Listed Location Countries ^ICMJE

France

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01564992

Other Study ID Numbers ^ICMJE

P 071240

Has Data Monitoring Committee

Plan to Share Data

IPD Description

Not Provided

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Christophe Corvol, MD, PhD

Asssitance Publique - Hopitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

May 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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