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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

Tracking Information
First Submitted Date February 23, 2012
First Posted Date March 28, 2012
Last Update Posted Date August 13, 2018
Actual Study Start Date May 2009
Estimated Primary Completion Date June 2019   (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
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 26, 2012)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2019
Estimated Primary Completion Date June 2019   (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 information is only displayed when the study is recruiting subjects
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
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor Assistance Publique - Hôpitaux de Paris
Original Study Sponsor Same as current
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 July 2018