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
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Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
Tracking Information | ||||
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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 |
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:
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: blood
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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
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Study Groups/Cohorts | Parkinson disease
Identification of genes
Intervention: Other: Identification of genes
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
Exclusion Criteria: - Atypical parkinsonism |
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Sex/Gender |
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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 |
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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 |
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PRS Account | Assistance Publique - Hôpitaux de Paris | |||
Verification Date | July 2018 |