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

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ClinicalTrials.gov Identifier: NCT01564992
Recruitment Status : Recruiting
First Posted : March 28, 2012
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Parkinson's Disease Other: Identification of genes

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 Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Interaction With Genes in Parkinson's Disease
Study Start Date : May 2009
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: polymorphism or haplotype


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. All complications of the disease or treatment [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men and women adults with a Parkinson Disease according to UKPDSBB criteria, diagnosed < 6 years
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Atypical parkinsonism

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564992


Contacts
Contact: Jean-Christophe Corvol, MD, PhD +33 1 42 16 57 66

Locations
France
Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Jean-Christophe Corvol, MD, PhD    +33 1 42 16 57 66      
Principal Investigator: Jean-Christophe Corvol, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Christophe Corvol, MD, PhD Asssitance Publique - Hopitaux de Paris
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01564992     History of Changes
Other Study ID Numbers: P 071240
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Parkinson's disease
Pharmacogenetics
Genetics

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases