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

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ClinicalTrials.gov Identifier: NCT01564992
Recruitment Status : Unknown
Verified July 2018 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : March 28, 2012
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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
Actual Study Start Date : May 2009
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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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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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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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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
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Contact: Jean-Christophe Corvol, MD, PhD +33 1 42 16 57 66

Locations
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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
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Principal Investigator: Jean-Christophe Corvol, MD, PhD Asssitance Publique - Hopitaux de Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01564992    
Other Study ID Numbers: P 071240
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: July 2018
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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases