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Drug Interaction With Genes in Parkinson's Disease (DIGPD)
This study is currently recruiting participants.
Verified June 2017 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01564992
First received: February 23, 2012
Last updated: June 27, 2017
Last verified: June 2017
| Tracking Information | |||||
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| First Received Date ICMJE | February 23, 2012 | ||||
| Last Updated Date | June 27, 2017 | ||||
| Start Date ICMJE | May 2009 | ||||
| Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
All complications of the disease or treatment [ Time Frame: 5 years ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01564992 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Drug Interaction With Genes in Parkinson's Disease | ||||
| Official Title ICMJE | 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 ICMJE | Observational | ||||
| Study Design ICMJE | 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 ICMJE | Parkinson's Disease | ||||
| Intervention ICMJE | 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 * | Not Provided | ||||
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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 ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 600 | ||||
| Estimated Completion Date | July 2018 | ||||
| Estimated Primary Completion Date | June 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Atypical parkinsonism |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01564992 | ||||
| Other Study ID Numbers ICMJE | P 071240 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | June 2017 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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