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Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740180
Recruitment Status : Terminated (No recruitment)
First Posted : December 4, 2012
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date November 30, 2012
First Posted Date December 4, 2012
Last Update Posted Date January 3, 2018
Actual Study Start Date March 25, 2015
Actual Primary Completion Date March 25, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2012)		 Presence/absence of cortico-sparing treatments [ Time Frame: baseline to 3 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 30, 2012)
  • Presence/absence of allergies [ Time Frame: Baseline (day 0) ]
    + description
  • Complete description of all treatments being taken [ Time Frame: Baseline (day 0) ]
  • CLIPPERS relapse severity [ Time Frame: Baseline (day 0) ]
    The rhythm and severity of relapses.
  • Relapse-free interval rhythm [ Time Frame: Baseline (day 0) ]
  • Weight (kg) [ Time Frame: Baseline (day 0) ]
  • Presence/absence of vascular risk factors [ Time Frame: Baseline (Day 0) ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: Baseline (day 0) ]
  • Presence/absence of allergies [ Time Frame: 6 months ]
    + description
  • Presence/absence of allergies [ Time Frame: 12 months ]
    + description
  • Presence/absence of allergies [ Time Frame: 18 months ]
    + description
  • Presence/absence of allergies [ Time Frame: 21 months ]
    + description
  • Presence/absence of allergies [ Time Frame: 24 months ]
    + description
  • Presence/absence of allergies [ Time Frame: 30 months ]
    + description
  • Presence/absence of allergies [ Time Frame: 36 months ]
    + description
  • Complete description of all treatments being taken [ Time Frame: 6 months ]
  • Complete description of all treatments being taken [ Time Frame: 12 months ]
  • Complete description of all treatments being taken [ Time Frame: 18 months ]
  • Complete description of all treatments being taken [ Time Frame: 21 months ]
  • Complete description of all treatments being taken [ Time Frame: 24 months ]
  • Complete description of all treatments being taken [ Time Frame: 30 months ]
  • Complete description of all treatments being taken [ Time Frame: 36 months ]
  • CLIPPERS relapse severity [ Time Frame: 6 months ]
    The rhythm and severity of relapses.
  • CLIPPERS relapse severity [ Time Frame: 12 months ]
    The rhythm and severity of relapses.
  • CLIPPERS relapse severity [ Time Frame: 18 months ]
    The rhythm and severity of relapses.
  • CLIPPERS relapse severity [ Time Frame: 21 months ]
    The rhythm and severity of relapses.
  • CLIPPERS relapse severity [ Time Frame: 24 months ]
    The rhythm and severity of relapses.
  • CLIPPERS relapse severity [ Time Frame: 30 months ]
    The rhythm and severity of relapses.
  • CLIPPERS relapse severity [ Time Frame: 36 months ]
    The rhythm and severity of relapses.
  • Relapse-free interval rhythm [ Time Frame: 6 months ]
  • Relapse-free interval rhythm [ Time Frame: 12 months ]
  • Relapse-free interval rhythm [ Time Frame: 18 months ]
  • Relapse-free interval rhythm [ Time Frame: 21 months ]
  • Relapse-free interval rhythm [ Time Frame: 24 months ]
  • Relapse-free interval rhythm [ Time Frame: 30 months ]
  • Relapse-free interval rhythm [ Time Frame: 36 months ]
  • Weight (kg) [ Time Frame: 6 months ]
  • Weight (kg) [ Time Frame: 12 months ]
  • Weight (kg) [ Time Frame: 18 months ]
  • Weight (kg) [ Time Frame: 21 months ]
  • Weight (kg) [ Time Frame: 24 months ]
  • Weight (kg) [ Time Frame: 30 months ]
  • Weight (kg) [ Time Frame: 36 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 6 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 12 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 18 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 21 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 24 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 30 months ]
  • Presence/absence of vascular risk factors [ Time Frame: 36 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 6 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 12 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 18 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 21 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 24 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 30 months ]
  • Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids [ Time Frame: 36 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 30, 2012)
  • Family history of auto-immune disease [ Time Frame: Baseline ]
  • Height (cm) [ Time Frame: Baseline (day 0) ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort
Official Title Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
Brief Summary The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.
Detailed Description 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

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

Patients will be recruited from referral centers throughout France. We also intend to communicate with all multiple sclerosis networks (French League against Multiple Sclerosis) to facilitate the detection of new cases.
Condition CLIPPERS
Intervention Other: 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.
Study Groups/Cohorts CLIPPERS patients

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

Intervention: Data entry

Intervention: Other: Data entry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 2, 2018)		 3
Original Estimated Enrollment
 (submitted: November 30, 2012)		 15
Actual Study Completion Date March 25, 2016
Actual Primary Completion Date March 25, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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
  • Presence of other diseases that could explain such clinical and radiological signs (see inclusion criteria)
  • If a cerebral biopsy has been performed, presence of signs of malignancy (eg, clonal proliferation, cellular atypia), vasculitis, granuloma, or demyelination
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01740180
Other Study ID Numbers LOCAL/2012/GT
Taieb Cohorte CLIPPERS ( Other Identifier: BESPIM, Nîmes University Hospital )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Centre Hospitalier Universitaire de Nīmes
Original Responsible Party Same as current
Current Study Sponsor Centre Hospitalier Universitaire de Nīmes
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Guillaume Taieb, MD Centre Hospitalier Universitaire de Nîmes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date January 2018