NCT01485549

Brief Summary

The main objectives are to determine on one hand whether oligomeric alpha-synuclein levels are increased in MSA patients compared to controls and on other hand whether there is a good agreement between cerebrospinal fluid (CSF) and plasma levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

November 26, 2012

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2018

Completed
Last Updated

June 27, 2019

Status Verified

February 1, 2019

Enrollment Period

6 years

First QC Date

November 29, 2011

Last Update Submit

June 26, 2019

Conditions

Multiple System Atrophy (MSA)

Keywords

Multiple system atrophy (MSA)alpha-synucleinopathiesbiological markerscerebrospinal fluidplasma

Outcome Measures

Primary Outcomes (1)

  • Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (CSF).

    Day 0

Secondary Outcomes (3)

  • Total alpha-synuclein concentration in CSF and oligomeric/total alpha-synuclein ratio in CSF

    Day 0

  • Oligomeric and total alpha-synuclein concentration in plasma and oligomeric/total alpha-synuclein ratio in plasma

    Day 0

  • Alpha-synuclein levels in relation to disease duration and age

    Day 0

Study Arms (2)

MSA Patients

Patients suffering from Multiple system atrophy (MSA)

Controls

Patients requiring spinal tap without being affected by a neurodegenerative disorder.

Eligibility Criteria

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

Cases will be selected from cohort of 90 MSA patients referenced in Bordeaux University Hospital. Controls will be selected from patients requiring spinal tap without being affected by a neurodegenerative disorder and paired in age and gender with cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Pessac, 33604, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

* cerebrospinal fluid (CSF) * whole blood * plasma * blood serum * urine

MeSH Terms

Conditions

Multiple System AtrophySynucleinopathies

Condition Hierarchy (Ancestors)

Primary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Wassilios MEISSNER, MD, PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 5, 2011

Study Start

November 26, 2012

Primary Completion

November 20, 2018

Study Completion

November 21, 2018

Last Updated

June 27, 2019

Record last verified: 2019-02

Locations

FR(1)