NCT02859805

Brief Summary

The objective of this study is to validate a diagnostic tool severity of these common non-motor manifestations, disturbing and little recognized as a self-questionnaire. This assessment tool used on different subgroups of patients (free from any treatment at an early stage of the disease and the stage of motor complications) will better understand the natural history of the non-motor fluctuations (FNM)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

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

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
Last Updated

August 9, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

July 28, 2016

Last Update Submit

August 4, 2016

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    Self questionnaires with Beck Depression Scale

    2 years

  • Quality of life

    use of measurement scales Quality of Life; PDQ-39 it's a 39-item Parkinson's disease questionnaire (Record socio-demographic information)

    2 years

Secondary Outcomes (4)

  • Socio-demographic data

    2 years

  • clinical evaluation

    2 years

  • clinical evaluation

    2 years

  • clinical evaluation

    2 years

Interventions

validation of a diagnostic tool severity of non-motor symptoms in Parkinson patientsOTHER

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient suffering from Parkinson's disease

You may qualify if:

  • Patient aged 30 or over Patient having an Parkinson's disease Patient hospitalized in one of the clinical sites participating in the project Patient have agreed to participate in the study subject that masters the French language and able to fulfill the self-questionnaire.

You may not qualify if:

  • Patient aged under 30 Patient can not answer the self-administered questionnaire Patient has not agreed to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Urielle DESALBRES

    Assistance Publique des Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 9, 2016

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

February 1, 2015

Last Updated

August 9, 2016

Record last verified: 2016-07