Clinical trial NCT01564992: Drug Interaction With Genes in Parkinson's Disease
Official title: Drug Interaction With Genes in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Pharmacogenetics
Genetics
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men and women adults with a Parkinson Disease according to UKPDSBB criteria, diagnosed \< 6 years

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

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

Primary outcomes:
measure: All complications of the disease or treatment
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Asssitance Publique - Hopitaux de Paris
name: Jean-Christophe Corvol, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.