NCT01564992

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 13, 2018

Status Verified

July 1, 2018

Enrollment Period

10.1 years

First QC Date

February 23, 2012

Last Update Submit

August 10, 2018

Conditions

Keywords

Parkinson's diseasePharmacogeneticsGenetics

Outcome Measures

Primary Outcomes (1)

  • All complications of the disease or treatment

    5 years

Study Arms (1)

Parkinson disease

Identification of genes

Other: Identification of genes

Interventions

Identification of genes which polymorphism or haplotype is associated with a complication of Parkinson disease, directly or with the interaction of treatment.

Also known as: polymorphism or haplotype
Parkinson disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men and women adults with a Parkinson Disease according to UKPDSBB criteria, diagnosed \< 6 years

You may qualify if:

  • Men and women, age \> 18.
  • Parkinson Disease according to UKPDSBB criteria
  • PD diagnosis \< 6 years
  • Informed consent

You may not qualify if:

  • \- Atypical parkinsonism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique Neuro - Bâtiment ICM - Hôpital Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (2)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Parkinson Disease

Interventions

Polymorphism, GeneticHaplotypes

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic PhenomenaGenotype

Study Officials

  • Jean-Christophe Corvol, MD, PhD

    Asssitance Publique - Hopitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Christophe Corvol, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

March 28, 2012

Study Start

May 1, 2009

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

August 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations