Drug Interaction With Genes in Parkinson's Disease (DIGPD)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2016 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 20, 2016
Last verified: May 2016
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Purpose
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 | Intervention |
|---|---|
|
Parkinson's Disease |
Other: Identification of genes |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Drug Interaction With Genes in Parkinson's Disease |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- All complications of the disease or treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
blood
| Estimated Enrollment: | 600 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564992
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564992
Contacts
| Contact: Jean-Christophe Corvol, MD, PhD | +33 1 42 16 57 66 |
Locations
| 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
| Principal Investigator: | Jean-Christophe Corvol, MD, PhD | Asssitance Publique - Hopitaux de Paris |
More Information
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01564992 History of Changes |
| Other Study ID Numbers: | P 071240 |
| Study First Received: | February 23, 2012 |
| Last Updated: | June 20, 2016 |
| Health Authority: | France: Ministry of Health |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Parkinson's disease Pharmacogenetics Genetics |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on September 30, 2016