NCT02627664

Brief Summary

The investigators prospectively enrolled 64 early PD patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2011

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

6 years

First QC Date

December 18, 2014

Last Update Submit

May 16, 2017

Conditions

Parkinson's Disease

Keywords

Idiopathic earlyParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • dysarthria severity assessed by the BECD scale

    BECD (French battery of clinical evaluation of the dysarthria) is a validated scale for qualitative assessment of dysarthria severity in neurological disorders, especially PD

    2 years

Secondary Outcomes (9)

  • respiratory insufficiency detection

    2 years

  • swallowing function

    2 years

  • gait axial function (freezing)

    2 years

  • Mattis scale

    2 years

  • LARS scale

    2 years

  • +4 more secondary outcomes

Study Arms (1)

observational study

natural history of non dopaminergic signs

Other: observational study

Interventions

observational studyOTHER

natural history of non dopaminergic signs

observational study

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Parkinson's disease (PD) with early idiopathic ( ≤ 5 years of evolution )

You may qualify if:

  • idiopathic parkinson's disease

You may not qualify if:

  • dementia
  • severe axial gait disorders
  • respiratory or ENT pathology
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Francine Niset

Lille, 59000, France

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • luc defebvre, MD PhD

    CHRU LILLE FRANCE

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 18, 2014

First Posted

December 11, 2015

Study Start

March 1, 2011

Primary Completion

February 9, 2017

Study Completion

February 9, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)