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

• ClinicalTrials.gov Identifier: NCT01564992
• Recruitment Status: Unknown
• First Posted: March 28, 2012
• Last Update Posted: August 13, 2018
• Sponsor: Assistance Publique - Hôpitaux de Paris
• 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
• 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 *

• Marques A, Vidal T, Pereira B, Benchetrit E, Socha J, Pineau F, Elbaz A, Artaud F, Mangone G, You H, Cormier F, Galitstky M, Pomies E, Rascol O, Derkinderen P, Weintraub D, Corvol JC, Durif F; DIGPD study group. French validation of the questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS). Parkinsonism Relat Disord. 2019 Jun;63:117-123. doi: 10.1016/j.parkreldis.2019.02.026. Epub 2019 Mar 4.
• Corvol JC, Artaud F, Cormier-Dequaire F, Rascol O, Durif F, Derkinderen P, Marques AR, Bourdain F, Brandel JP, Pico F, Lacomblez L, Bonnet C, Brefel-Courbon C, Ory-Magne F, Grabli D, Klebe S, Mangone G, You H, Mesnage V, Lee PC, Brice A, Vidailhet M, Elbaz A; DIGPD Study Group. Longitudinal analysis of impulse control disorders in Parkinson disease. Neurology. 2018 Jul 17;91(3):e189-e201. doi: 10.1212/WNL.0000000000005816. Epub 2018 Jun 20.

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

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