CLIPPERSNCT01740180
Cortico-saving Treatments Proposed for CLIPPERS: a First Cohort
An observational study of CLIPPERS, run by Centre Hospitalier Universitaire de Nīmes at 11 sites in France.
Trial summary
The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CLIPPERS
- What is being tested?
- Data entry
- How many people
- 3 participants
- Where
- 11 sitesFrance
- Study dates
- 25 Mar 2015to 25 Mar 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHU de Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
CH de Dax - Côte d'Argent
Dax, 40100
CHU de Limoges - Hôpital Dupuytren
Limoges, 87042
APHM - Hôpital La Timone Adultes
Marseille, 13385
CHU de Montpellier - Hôpital Saint-Eloi
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
CHU de Rouen - Hôpital Charles Nicolle
Rouen, 76031
CHRU de Strasbourg - Hôpital Civil
Strasbourg, 67091
CHRU de Toulouse - Hôpital de Rangueil
Toulouse, 31059
CHRU de Toulouse - Hôpital Purpan
Toulouse, 31059
CHRU de Tours - Hôpital Bretonneau
Tours, 37044
About this study
Official title: Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
The primary objective of this study is to collect information about how CLIPPERS patients are currently being treated in France.
Read the 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.
- Conditions
- CLIPPERS
- Being tested
- Data entry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data entryOther
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 group | Role | What they receive |
|---|---|---|
| CLIPPERS patients | The population concerned by this study consists of patients diagnosed according to CLIPPERS criteria (see inclusion and exclusion criteria).
Intervention: Data entry Receives: Other: Data entry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence/absence of cortico-sparing treatments
Measured: baseline to 3 years
Secondary outcomes (56)
Presence/absence of allergies
+ description
Measured: Baseline (day 0)
Complete description of all treatments being taken
Measured: Baseline (day 0)
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: Baseline (day 0)
Relapse-free interval rhythm
Measured: Baseline (day 0)
Weight (kg)
Measured: Baseline (day 0)
Presence/absence of vascular risk factors
Measured: Baseline (Day 0)
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: Baseline (day 0)
Presence/absence of allergies
+ description
Measured: 6 months
Presence/absence of allergies
+ description
Measured: 12 months
Presence/absence of allergies
+ description
Measured: 18 months
Presence/absence of allergies
+ description
Measured: 21 months
Presence/absence of allergies
+ description
Measured: 24 months
Presence/absence of allergies
+ description
Measured: 30 months
Presence/absence of allergies
+ description
Measured: 36 months
Complete description of all treatments being taken
Measured: 6 months
Complete description of all treatments being taken
Measured: 12 months
Complete description of all treatments being taken
Measured: 18 months
Complete description of all treatments being taken
Measured: 21 months
Complete description of all treatments being taken
Measured: 24 months
Complete description of all treatments being taken
Measured: 30 months
Complete description of all treatments being taken
Measured: 36 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 6 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 12 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 18 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 21 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 24 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 30 months
CLIPPERS relapse severity
The rhythm and severity of relapses.
Measured: 36 months
Relapse-free interval rhythm
Measured: 6 months
Relapse-free interval rhythm
Measured: 12 months
Relapse-free interval rhythm
Measured: 18 months
Relapse-free interval rhythm
Measured: 21 months
Relapse-free interval rhythm
Measured: 24 months
Relapse-free interval rhythm
Measured: 30 months
Relapse-free interval rhythm
Measured: 36 months
Weight (kg)
Measured: 6 months
Weight (kg)
Measured: 12 months
Weight (kg)
Measured: 18 months
Weight (kg)
Measured: 21 months
Weight (kg)
Measured: 24 months
Weight (kg)
Measured: 30 months
Weight (kg)
Measured: 36 months
Presence/absence of vascular risk factors
Measured: 6 months
Presence/absence of vascular risk factors
Measured: 12 months
Presence/absence of vascular risk factors
Measured: 18 months
Presence/absence of vascular risk factors
Measured: 21 months
Presence/absence of vascular risk factors
Measured: 24 months
Presence/absence of vascular risk factors
Measured: 30 months
Presence/absence of vascular risk factors
Measured: 36 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 6 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 12 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 18 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 21 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 24 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 30 months
Number of relapses in the past 6 months while taking >= 20 mg/ day corticoids
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start25 Mar 2015
- Primary completion25 Mar 2016
- Study completion25 Mar 2016
Why it stopped: No recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CLIPPERSStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Taieb, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740180
- Sponsor's protocol ID
- LOCAL/2012/GT
- Other IDs
- Taieb Cohorte CLIPPERS
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2012
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortico-saving Treatments Proposed for CLIPPERS (Chronic Lymphocytic Inflammation With Pontine Perivascular Responsive to Steroids): a First Cohort
- ClinicalTrials.gov ID
- NCT01740180
- Acronym / sponsor ID
- LOCAL/2012/GT
- Conditions
- CLIPPERS
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 25 Mar 2015 (actual)
- Primary completion
- 25 Mar 2016 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLIPPERS patients | – | Other: Data entryThe population concerned by this study consists of patients diagnosed according to CLIPPERS criteria (see inclusion and exclusion criteria). Intervention: Data entry |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data entryThis 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. | Other | CLIPPERS patients |
Primary outcome
Presence/absence of cortico-sparing treatments
Time frame: baseline to 3 years
56 secondary outcomes
Presence/absence of allergies
Time frame: Baseline (day 0)
Complete description of all treatments being taken
Time frame: Baseline (day 0)
CLIPPERS relapse severity
Time frame: Baseline (day 0)
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
Presence/absence of allergies
Time frame: 12 months
Presence/absence of allergies
Time frame: 18 months
Presence/absence of allergies
Time frame: 21 months
Presence/absence of allergies
Time frame: 24 months
Presence/absence of allergies
Time frame: 30 months
Presence/absence of allergies
Time frame: 36 months
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
CLIPPERS relapse severity
Time frame: 12 months
CLIPPERS relapse severity
Time frame: 18 months
CLIPPERS relapse severity
Time frame: 21 months
CLIPPERS relapse severity
Time frame: 24 months
CLIPPERS relapse severity
Time frame: 30 months
CLIPPERS relapse severity
Time frame: 36 months
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
Results and safety
The study was stopped early (reason given: No recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Taieb, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CLIPPERS, run by Centre Hospitalier Universitaire de Nīmes at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence/absence of cortico-sparing treatments (time frame: baseline to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.