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

Tracking Information
First Submitted Date	February 23, 2012
First Posted Date	March 28, 2012
Last Update Posted Date	June 28, 2017
Study Start Date	May 2009
Estimated Primary Completion Date	June 2018 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: March 26, 2012)	All complications of the disease or treatment [ Time Frame: 5 years ]
Original Primary Outcome Measures	Same as current
Change History	Complete list of historical versions of study NCT01564992 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Drug Interaction With Genes in Parkinson's Disease
Official Title	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	Observational
Study Design	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	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.; Other Name: polymorphism or haplotype
Study Groups/Cohorts	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	Recruiting
Estimated Enrollment; (submitted: March 26, 2012)	600
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	July 2018
Estimated Primary Completion Date	June 2018 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Men and women, age > 18.; Parkinson Disease according to UKPDSBB criteria; PD diagnosis < 6 years; Informed consent Exclusion Criteria: - Atypical parkinsonism
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact: Jean-Christophe Corvol, MD, PhD +33 1 42 16 57 66
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT01564992
Other Study ID Numbers	P 071240
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Assistance Publique - Hôpitaux de Paris
Study Sponsor	Assistance Publique - Hôpitaux de Paris
Collaborators	Not Provided
Investigators	Principal Investigator: Jean-Christophe Corvol, MD, PhD Asssitance Publique - Hopitaux de Paris
PRS Account	Assistance Publique - Hôpitaux de Paris
Verification Date	June 2017