SUSAC's SyndromeCARESSNCT01481662
Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome
An observational study of SUSAC's Syndrome and Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SUSAC's Syndrome, Encephalopathy, Hearing Loss
- What is being tested?
- Diffusion tensor magnetic resonance imaging of the brain
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to May 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Hundreds of patients with SS, mostly young women, have been reported.
Who may be able to join
- Age older than 18
- Two clinical features of the triad present: encephalopathy, sensorineural hearing loss assessed by audiogram, retinal artery occlusion assessed by fundoscopy or fluorescein retinal angiography.
- Written informed consent provided. In case of subjects unable to give a written informed consent because of encephalopathy associated with the disease, a written statement of non-opposition should be signed by a relative. This non-opposition statement should be then confirmed by the subject as soon as possible.
- Realization of a medical examination beforehand
Who cannot join
- Alternative diagnosis: multiple sclerosis, mitochondriopathy, Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL), primary brain tumor, Lyme disease.
- In case of associated disease (autoimmune disease, tumor, metabolical disease,…), inclusion will need further analysis by the expert comity.
- Not membership in a national insurance scheme
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital BICHAT
Paris, 75018
Thomas PAPO, Pr, (1)40258705 ext. +33, thomas.papo@aphp.fr
Karim SACRE, Pr, karim.sacre@aphp.fr
About this study
Official title: Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome (RETINOCOCHLEOCEREBRAL Vasculopathy)
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.
The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, the investigators will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.
Read the detailed description
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.
The diagnosis of SS is difficult because its characteristic signs often do not occur simultaneously or may be too subtle for the patient to notice. Neurological features of SS may occur several months prior to other symptoms. The retinal artery branch occlusion, by occurring in the peripheral portion of the retina, may remain asymptomatic. Sensorineural hearing loss may also be asymptomatic and disclosed only by audiogram. Besides mild pleocytosis in cerebrospinal fluid, all performed biological tests are virtually negative. No infectious agent, consistent autoimmune marker, or coagulopathy has been disclosed. Changes seen on brain MRI are well characterized although not specific. The only site from which biopsy material is available for pathological analysis is the brain. The most common finding in brain biopsies is the presence of microinfarcts but brain biopsy is not currently performed.
Although the treatment of SS has not been studied in controlled trials, most patients have a good response to treatment with glucocorticoids, with the addition of anti-thrombotic therapy and, for cases in which the disease is refractory to steroids, intravenous immune globulin or cyclophosphamide. The clinical course is characterized by recurrent attacks involving 1 or more components of the triad that characterize the active phase of the disease. Remission usually occurs after the active phase but some patients show residual mild to moderate dementia or gait disturbance, and impaired hearing and vision.
SUSAC's Syndrome is a vasculopathy causing small infarcts in the cochlea, retina and brain. Proposed explanations include a hypercoagulable state, vasospasm, and vasculitis, none of which are supported by laboratory results or findings on brain biopsies. The unique distribution of arteriolar disease affecting the brain, the retina, and the cochlea suggests selective vulnerability of these three structures. The brain, retina, and cochlea all have a blood-tissue barrier, and the endothelium in these sites shares a common embryologic origin and unique structural and antigenic characteristics. It has therefore been proposed that SS is an autoimmune disease in which the endothelium is the primary target, and damage to the endothelium triggers arteriolar occlusion and microinfarcts. However, the pathogenesis remains unknown.
The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, we will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.
Because SUSAC's syndrome is a rare disease, we expect to include one hundred patients in this cohort. The constitution of the cohort and the collection of the samples will last for 2 years and half.
The conclusion of the study, based on statistical analysis done once all patients will be included in the cohort, should allow new recommendations in the diagnosis strategy and give new understandings of the therapeutic management of the disease. The result of this study may also give rise to hypothesis for an interventional study.
It's important to underline that this study must be considered as an interventional study.
Indeed, in this study the patients have a specific MRI, the acquisition of the sequences is with diffusion tensor. While in common practice the patients have only classical MRI without this specific sequences which is the routinely technique used.
- Being tested
- Diffusion tensor magnetic resonance imaging of the brain
- Keywords
- SUSAC's Syndrome, encephalopathy, hearing loss, retinal artery branch occlusions, Diffusion tensor MRI
- Medical subject headings
- Susac Syndrome, Brain Diseases, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion tensor magnetic resonance imaging of the brainDevice
Also called Diffusion tensor MRI
Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease.
| Study group | Role | What they receive |
|---|---|---|
| retrospective | cases retrospectively reported the last 20 years | |
| Prospective | Diffusion tensor magnetic resonance imaging of the brain:
new cases prospectively reported Receives: Device: Diffusion tensor magnetic resonance imaging of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
Measured: 1 year
Secondary outcomes (7)
diffusion MRI
diffusion MRI results
Measured: 12 months
serum sample
all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers
Measured: day 1
cerebrospinal fluid sample
all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers
Measured: day 1
DNA sample
all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers
Measured: day 1
RNA sample
all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers
Measured: day 1
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
Measured: 5 years
Peripheral Blood Mononuclear Cell
all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SUSAC's SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas PAPO, Pr, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481662
- Sponsor's protocol ID
- P081261
- Other IDs
- AOM09039
- Acronym
- CARESS
- Status last verified
- Jun 2017
- First submitted
- 22 Nov 2011
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Gaudemer A, Henry-Feugeas MC, Peyre M, Kachaner A, Klein I, Khalil A, Papo T, Sacre K. Brain microstructural damage through serial diffusion tensor imaging and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2025 Jan;32(1):e70002. doi: 10.1111/ene.70002.
PubMed 39686647Kachaner A, Mageau A, Goulenok T, Francois C, Delory N, Chauveheid MP, Laouenan C, Doan S, Halimi C, Klein I, Papo T, Sacre K; French Susac Study Group. Immunosuppressive agents or intravenous immunoglobulin in addition to glucocorticoids in the treatment of Susac syndrome: a French national cohort study. Lancet Rheumatol. 2025 Jan;7(1):e15-e20. doi: 10.1016/S2665-9913(24)00220-0. Epub 2024 Sep 18.
PubMed 39305913Peyre M, Mageau A, Henry Feugeas MC, Doan S, Halimi C, Klein I, Goulenok T, Francois C, Chauveheid MP, Papo T, Sacre K; French Susac Study Group. Risk factors for severe hearing loss in Susac syndrome: A national cohort study. Eur J Neurol. 2024 May;31(5):e16211. doi: 10.1111/ene.16211. Epub 2024 Jan 18.
PubMed 38235955Scheifer C, Henry Feugeas MC, Roriz M, Cohen Aubart F, Doan S, Jouvent E, Klein I, Machado C, Rouzaud D, Papo T, Sacre K; French Susac Study Group. Brain magnetic resonance imaging lesion load at diagnosis, severity at onset and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2022 Jan;29(1):121-129. doi: 10.1111/ene.15062. Epub 2021 Aug 23.
PubMed 34382290David C, Papo T, Ba I, Ollivier E, Boileau C, Dieude P, Keren B, Kannengiesser C, Sacre K. Hunting for the genetic basis of Susac syndrome. Eur J Neurol. 2021 Jul;28(7):e57-e59. doi: 10.1111/ene.14836. Epub 2021 Apr 7. No abstract available.
PubMed 33773011Machado S, Jouvent E, Klein I, De Guio F, Machado C, Cohen-Aubart F, Sacre K, Papo T. Cognitive dysfunction and brain atrophy in Susac syndrome. J Neurol. 2020 Apr;267(4):994-1003. doi: 10.1007/s00415-019-09664-8. Epub 2019 Dec 11.
PubMed 31828475
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome (RETINOCOCHLEOCEREBRAL Vasculopathy)
- ClinicalTrials.gov ID
- NCT01481662
- Acronym / sponsor ID
- CARESS / P081261
- Keywords
- SUSAC's Syndrome, encephalopathy, hearing loss, retinal artery branch occlusions, Diffusion tensor MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 29 Nov 2011 (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.
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.
The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, the investigators will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, and DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.
Detailed description
SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Since the first description of SS in 1979, hundreds of patients with SS, mostly young women, have been reported. However, comprehensive epidemiological, clinical and etiological features of SS have never been specifically addressed so far.
The diagnosis of SS is difficult because its characteristic signs often do not occur simultaneously or may be too subtle for the patient to notice. Neurological features of SS may occur several months prior to other symptoms. The retinal artery branch occlusion, by occurring in the peripheral portion of the retina, may remain asymptomatic. Sensorineural hearing loss may also be asymptomatic and disclosed only by audiogram. Besides mild pleocytosis in cerebrospinal fluid, all performed biological tests are virtually negative. No infectious agent, consistent autoimmune marker, or coagulopathy has been disclosed. Changes seen on brain MRI are well characterized although not specific. The only site from which biopsy material is available for pathological analysis is the brain. The most common finding in brain biopsies is the presence of microinfarcts but brain biopsy is not currently performed.
Although the treatment of SS has not been studied in controlled trials, most patients have a good response to treatment with glucocorticoids, with the addition of anti-thrombotic therapy and, for cases in which the disease is refractory to steroids, intravenous immune globulin or cyclophosphamide. The clinical course is characterized by recurrent attacks involving 1 or more components of the triad that characterize the active phase of the disease. Remission usually occurs after the active phase but some patients show residual mild to moderate dementia or gait disturbance, and impaired hearing and vision.
SUSAC's Syndrome is a vasculopathy causing small infarcts in the cochlea, retina and brain. Proposed explanations include a hypercoagulable state, vasospasm, and vasculitis, none of which are supported by laboratory results or findings on brain biopsies. The unique distribution of arteriolar disease affecting the brain, the retina, and the cochlea suggests selective vulnerability of these three structures. The brain, retina, and cochlea all have a blood-tissue barrier, and the endothelium in these sites shares a common embryologic origin and unique structural and antigenic characteristics. It has therefore been proposed that SS is an autoimmune disease in which the endothelium is the primary target, and damage to the endothelium triggers arteriolar occlusion and microinfarcts. However, the pathogenesis remains unknown.
The objective of this study is to characterize the epidemiological, clinical, and etiological features of SUSAC's Syndrome. In this aim, we will constitute a national clinical-based cohort including all SS cases retrospectively reported in France since the last 20 years and all new cases prospectively observed. French Society of Neurology, Ophthalmology and Internal Medicine will be asked to collaborate. Every case will be reviewed by an expert comity of internists, neurologists and neuroradiologists to validate the diagnosis. The exhaustive and systematic analysis of each case will help to better define different aspects of the disease such as the incidence and prevalence, the clinical presentation, the diagnostic modalities and the impact of treatments. Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. Serum, cerebrospinal fluid, DNA samples from each patient will also be collected to study potential autoimmune, thrombotic and infectious markers.
Because SUSAC's syndrome is a rare disease, we expect to include one hundred patients in this cohort. The constitution of the cohort and the collection of the samples will last for 2 years and half.
The conclusion of the study, based on statistical analysis done once all patients will be included in the cohort, should allow new recommendations in the diagnosis strategy and give new understandings of the therapeutic management of the disease. The result of this study may also give rise to hypothesis for an interventional study.
It's important to underline that this study must be considered as an interventional study.
Indeed, in this study the patients have a specific MRI, the acquisition of the sequences is with diffusion tensor. While in common practice the patients have only classical MRI without this specific sequences which is the routinely technique used.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retrospective | – | –cases retrospectively reported the last 20 years |
| Prospective | – | Device: Diffusion tensor magnetic resonance imaging of the brainDiffusion tensor magnetic resonance imaging of the brain: new cases prospectively reported |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SUSAC's Syndrome (SS) is characterized by the clinical triad of encephalopathy, hearing loss, and retinal artery branch occlusions. Hundreds of patients with SS, mostly young women, have been reported.
Key inclusion criteria (4 listed)
- Age older than 18
- Two clinical features of the triad present: encephalopathy, sensorineural hearing loss assessed by audiogram, retinal artery occlusion assessed by fundoscopy or fluorescein retinal angiography.
- Written informed consent provided. In case of subjects unable to give a written informed consent because of encephalopathy associated with the disease, a written statement of non-opposition should be signed by a relative. This non-opposition statement should be then confirmed by the subject as soon as possible.
- Realization of a medical examination beforehand
Key exclusion criteria (3 listed)
- Alternative diagnosis: multiple sclerosis, mitochondriopathy, Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy (CADASIL), primary brain tumor, Lyme disease.
- In case of associated disease (autoimmune disease, tumor, metabolical disease,…), inclusion will need further analysis by the expert comity.
- Not membership in a national insurance scheme
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 |
|---|---|---|
| Diffusion tensor magnetic resonance imaging of the brainAlso: Diffusion tensor MRIDiffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease. | Device | Prospective |
Primary outcome
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
Time frame: 1 year
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
7 secondary outcomes
diffusion MRI
Time frame: 12 months
serum sample
Time frame: day 1
cerebrospinal fluid sample
Time frame: day 1
DNA sample
Time frame: day 1
RNA sample
Time frame: day 1
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome
Time frame: 5 years
Peripheral Blood Mononuclear Cell
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
- Derived from this study: PubMed 39686647Gaudemer A, Henry-Feugeas MC, Peyre M, Kachaner A, Klein I, Khalil A, Papo T, Sacre K. Brain microstructural damage through serial diffusion tensor imaging and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2025 Jan;32(1):e70002. doi: 10.1111/ene.70002.
- Derived from this study: PubMed 39305913Kachaner A, Mageau A, Goulenok T, Francois C, Delory N, Chauveheid MP, Laouenan C, Doan S, Halimi C, Klein I, Papo T, Sacre K; French Susac Study Group. Immunosuppressive agents or intravenous immunoglobulin in addition to glucocorticoids in the treatment of Susac syndrome: a French national cohort study. Lancet Rheumatol. 2025 Jan;7(1):e15-e20. doi: 10.1016/S2665-9913(24)00220-0. Epub 2024 Sep 18.
- Derived from this study: PubMed 38235955Peyre M, Mageau A, Henry Feugeas MC, Doan S, Halimi C, Klein I, Goulenok T, Francois C, Chauveheid MP, Papo T, Sacre K; French Susac Study Group. Risk factors for severe hearing loss in Susac syndrome: A national cohort study. Eur J Neurol. 2024 May;31(5):e16211. doi: 10.1111/ene.16211. Epub 2024 Jan 18.
- Derived from this study: PubMed 34382290Scheifer C, Henry Feugeas MC, Roriz M, Cohen Aubart F, Doan S, Jouvent E, Klein I, Machado C, Rouzaud D, Papo T, Sacre K; French Susac Study Group. Brain magnetic resonance imaging lesion load at diagnosis, severity at onset and outcomes in Susac syndrome: A prospective cohort study. Eur J Neurol. 2022 Jan;29(1):121-129. doi: 10.1111/ene.15062. Epub 2021 Aug 23.
- Derived from this study: PubMed 33773011David C, Papo T, Ba I, Ollivier E, Boileau C, Dieude P, Keren B, Kannengiesser C, Sacre K. Hunting for the genetic basis of Susac syndrome. Eur J Neurol. 2021 Jul;28(7):e57-e59. doi: 10.1111/ene.14836. Epub 2021 Apr 7. No abstract available.
- Derived from this study: PubMed 31828475Machado S, Jouvent E, Klein I, De Guio F, Machado C, Cohen-Aubart F, Sacre K, Papo T. Cognitive dysfunction and brain atrophy in Susac syndrome. J Neurol. 2020 Apr;267(4):994-1003. doi: 10.1007/s00415-019-09664-8. Epub 2019 Dec 11.
- Individual participant dataSharing planned: Undecided
Related trials for SUSAC's Syndrome
RecruitingObservational study
Phenotypic and Etiological Characterization of Susac Syndrome
Susac Syndrome
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.
Thomas PAPO, Pr principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SUSAC's Syndrome and Encephalopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas PAPO, Pr ((1)40258705 ext. +33, thomas.papo@bch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481662, which also lists 6 linked publications.
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 21 Dec 2017; AzTrials last refreshed its copy on 8 Nov 2026.