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

August 10, 2018 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Recruiting
        • Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière
        • Contact:
          • Jean-Christophe Corvol, MD, PhD
          • Phone Number: +33 1 42 16 57 66
        • Principal Investigator:
          • Jean-Christophe CORVOL, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Atypical parkinsonism

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parkinson disease
Identification of genes
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 Names:
  • polymorphism or haplotype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All complications of the disease or treatment
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jean-Christophe Corvol, MD, PhD, Asssitance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2009

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

February 23, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Actual)

August 13, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 071240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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