NCT01371071

Brief Summary

A majority of patients with multiple sclerosis initially presents with a single demyelinating event, e.g. in the optic nerves, brain, brainstem or spinal cord, referred to as a clinically isolated syndrome (CIS). Not all patients with CIS get a relapse and develop multiple sclerosis but in those patients who do, irreversible damage of the central nervous system, e.g. axonal damage, is already detectable in that early stage of disease. Early initiation of immunomodulatory therapy is crucial for patients with clinically isolated syndrome who are at high risk for the development of multiple sclerosis. Vice versa identification of low risk patients could help to avoid an unnecessary therapy. In this prospective observational study we want to follow up patients with CIS and early multiple sclerosis over a period of four years and obtain clinical, laboratory and MRI - data in order to identify risk factors for relapses, prognostic factors and therapy response markers.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 10, 2011

Status Verified

June 1, 2011

Enrollment Period

6.9 years

First QC Date

June 8, 2011

Last Update Submit

June 9, 2011

Conditions

Multiple Sclerosis, MSClinically Isolated Syndrome

Keywords

Clinically isolated syndrome (CIS)Multiple sclerosis (MS)Immunomodulatory therapyPrognostic markersMRIOCT

Outcome Measures

Primary Outcomes (1)

  • time (in days) until relapse during the observation period of four years

    48 months

Secondary Outcomes (3)

  • MRI - parameters: number and volume of T2 and gadolinium enhancing lesions, analysis of lesion patterns (spinal und cerebral MRI)

    48 months

  • biomarkers: RNA, microRNA, DNA, proteins, enzymes, autoantibodies, antiviral antibodies, virus DNA, Vitamin D and lipids in serum, plasma, peripheral cells, urine, saliva and CSF

    48 months

  • Optical Coherence Tomography (OCT): thickness of the retinal nerve fibre layer (RNFL) or total macular volume (TMV)

    48 months

Study Arms (1)

CIS or early relapsing-remitting MS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be recruted at neurological outpatient clinics and neurologcial clinics of the charité and neurologists' medical practices.

You may qualify if:

  • age \> 18 years
  • signed informed consent
  • clinically isolated syndrome within the last 6 months
  • diagnosis of multiple sclerosis within the last two years

You may not qualify if:

  • eye disease that could interfere with OCT (e.g. glaucoma, diabetic retinopathy)
  • secondary progressive multiple sclerosis
  • pregnancy
  • contraindications for MRI, e.g. pacemaker, metal implants, allergy against gadolinium
  • alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurology, Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Related Publications (1)

  • Gottwald NS, Asseyer S, Chien C, Brasanac J, Nauman AT, Rust R, Schmitz-Hubsch T, Strobl JB, Ruprecht K, Paul F, Regitz-Zagrosek V, Gold SM, Sperber PS. Impact of sex on clinical outcome in early Multiple Sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105749. doi: 10.1016/j.msard.2024.105749. Epub 2024 Jun 29.

    PMID: 38959589DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood samples (serum and plasma, with DNA), urine, saliva, CSF (if routine lumbar puncture was performed, no additional lumbar punctures for the study)

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Friedemann Paul, Prof.

    Charite - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

  • Klemens Ruprecht, Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • Judith Bellmann-Strobl, Dr.

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Friedemann Paul, Prof.

CONTACT

0049 30 450friedemann.paul@charite.de

Klemens Ruprecht, Dr.

CONTACT

0049 30 450klemens.ruprecht@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 8, 2011

First Posted

June 10, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 10, 2011

Record last verified: 2011-06

Locations

DE(2)