NCT01651520

Brief Summary

In this study the investigators will use PET and 11C-Flumazenil to visualize and quantify neuronal injury in the cortex and the deep gray matter of Multiple Sclerosis patients at an early stage. The investigators will follow up patients to determine the prognostic value of this neuronal injury.

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
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable multiple-sclerosis

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

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 16, 2017

Status Verified

August 1, 2017

Enrollment Period

6 years

First QC Date

July 25, 2012

Last Update Submit

August 14, 2017

Conditions

Multiple Sclerosis

Keywords

NeurodegenerationDisabilityCognitionPrognosis

Outcome Measures

Primary Outcomes (1)

  • neuronal imaging

    Prognosis value of the neuronal imaging on 2 years evolution (atrophy and EDSS)

    2 years

Study Arms (4)

Relapsing patients < 5 years

EXPERIMENTAL

Relapsing patients \< 5 years

Drug: PET with 11C-Flumazenil

relapsing patients < 10 years

EXPERIMENTAL

relapsing patients \< 10 years

Drug: PET with 11C-Flumazenil

primary progressive patients < 10 years

EXPERIMENTAL

primary progressive patients \< 10 years

Drug: PET with 11C-Flumazenil

healthy volunteers

OTHER

healthy volunteers

Drug: PET with 11C-Flumazenil

Interventions

PET with 11C-FlumazenilDRUG

PET with 11C-Flumazenil.

Relapsing patients < 5 yearshealthy volunteersprimary progressive patients < 10 yearsrelapsing patients < 10 years

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Four groups of subjects will be included:
  • patients with a RRMS evolving since less than 5 years (revised Mc Donald criteria, n=20);
  • patients with a RRMS evolving since more than 5 years and less than 10 years (n=20);
  • patients with a primary progressive MS (PPMS) evolving since less than 10 years (n=20);
  • Healthy volunteers matched for age and sex (2/3 matched with RRMS patients; 1/3 matched with PPMS patients).

You may not qualify if:

  • Lack of social insurance
  • Pregnancy
  • Age \> 55
  • Therapy with benzodiazepine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pitié Salpêtrière Hospital

Paris, 75013, France

Location

Related Publications (1)

  • Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6):e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.

    PMID: 36229188DERIVED

MeSH Terms

Conditions

Multiple SclerosisNerve Degeneration

Interventions

2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bruno Stankoff, MD, PhD

    APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

June 1, 2013

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

August 16, 2017

Record last verified: 2017-08

Locations

FR(1)