Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005549

Trial Description

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Title

Investigation of Relevant Biomarkers in Patients With Susac Syndrome

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult.
The aim of this investigation is to identify relevant biomarkers and to elucidate the
pathogenesis of Susac syndrome

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Brief Summary in Scientific Language

Susac Syndrome is a rare disease characterized by encephalopathy, branch retinal artery
occlusion and sensorineural deafness. The pathogenesis is not yet clear, an autoimmune
endotheliopathy is discussed. Because of the variable and often incomplete clinical
presentation, the establishment of the diagnosis is often delayed or even completely missed.

The aim of this study is to identify biomarkers that facilitate the reliable and prompt
establishment of the diagnosis. Patients with a definite diagnosis of Susac syndrome and
healthy subjects as controls are investigated.

Furthermore, the correlation of serological markers with structural retinal and cerebral
changes will contribute to clarification of the pathogenesis of Susac syndrome.

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Organizational Data

  •   DRKS00005549
  •   2014/04/23
  •   2011/01/06
  •   yes
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Secondary IDs

  •   NCT01273792  (ClinicalTrials.gov)
  •   Biomarkers Susac Syndrome  (Charite University, Berlin, Germany)
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Health Condition or Problem studied

  •   Susac Syndrome
  •   I67.7 -  Cerebral arteritis, not elsewhere classified
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Interventions/Observational Groups

  • [---]*
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- disease specific patterns of pathology on cranial MRI; one-time cranial MRI
- disease specific patterns of pathology in optical coherence tomography; one time optical coherence tomography
- serological biomarkers; time frame: not defined, cross-sectional analysis

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2010/05/31
  •   30
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- adult male and female patients with definite Susac syndrome or matching healthy
control subjects

- ability to provide informed consent

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Exclusion Criteria

- pregnancy

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Addresses

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    • Charite University, Berlin, Germany
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    • NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
    • Jan M Dörr, MD 
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    • Jan M Dörr, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Dörr J, Radbruch H, Bock M, Wuerfel J, Brüggemann A, Wandinger KP, Zeise D, Pfueller CF, Zipp F, Paul F. Encephalopathy, visual disturbance and hearing loss-recognizing the symptoms of Susac syndrome. Nat Rev Neurol. 2009 Dec;5(12):683-8.; 19953118
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.