Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

NCT ID: NCT01740180

Last Updated: 2018-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-25

Study Completion Date

2016-03-25

Brief Summary

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The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.

Detailed Description

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This is an observational study. Data will be prospectively collected, starting with a detailed baseline description of disease and treatment status, followed by updates everything six months for the next three years.

Conditions

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CLIPPERS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CLIPPERS patients

The population concerned by this study consists of patients diagnosed according to CLIPPERS criteria (see inclusion and exclusion criteria).

Intervention: Data entry

Data entry

Intervention Type OTHER

This cohort describes the basic information about the patients (age, sex, weight, height, background) as well as acts required, treatment and results of imaging studies.

These data are extracted from patient records by each participating center and collected in an e-CRF.

Interventions

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Data entry

This cohort describes the basic information about the patients (age, sex, weight, height, background) as well as acts required, treatment and results of imaging studies.

These data are extracted from patient records by each participating center and collected in an e-CRF.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient correctly informed about the study
* Symptoms and/or clinical signs indicating that the brain stem is affected
* MRI shows punctate gadolinium highlights and/or curvilinear bridge and/or middle cerebellar peduncles
* Clinical and radiological cortico sensitivity
* If a cerebral biopsy has been performed, presence of a lymphocytic, histiocytic or lympho-hysticytic infiltrate

* If a cerebral biopsy has been performed, presence of signs of malignancy (eg, clonal proliferation, cellular atypia), vasculitis, granuloma, or demyelination

Exclusion Criteria

* symptoms and/or clinical signs indicating impairment other than the central nervous system
* Cortical impairment present on MRI, microbleeds, stenosis on magnetic resonance angiography, or pacchymeningitis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Taieb, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

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CHU de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

CH de Dax - Côte d'Argent

Dax, , France

Site Status

CHU de Limoges - Hôpital Dupuytren

Limoges, , France

Site Status

APHM - Hôpital La Timone Adultes

Marseille, , France

Site Status

CHU de Montpellier - Hôpital Saint-Eloi

Montpellier, , France

Site Status

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Site Status

CHU de Rouen - Hôpital Charles Nicolle

Rouen, , France

Site Status

CHRU de Strasbourg - Hôpital Civil

Strasbourg, , France

Site Status

CHRU de Toulouse - Hôpital de Rangueil

Toulouse, , France

Site Status

CHRU de Toulouse - Hôpital Purpan

Toulouse, , France

Site Status

CHRU de Tours - Hôpital Bretonneau

Tours, , France

Site Status

Countries

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France

Other Identifiers

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Taieb Cohorte CLIPPERS

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2012/GT

Identifier Type: -

Identifier Source: org_study_id

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