ROLE OF ENDOTHELIAL INFLAMMATION IN DEMYELINATING DISEASES OF THE CENTRAL NERVOUS SYSTEM

Phase 1

• Conditions: Mulple Sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2014-000254-11-DK
• Lead Sponsor: Department of Neurology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-03-28
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria
To be eligible to participate in this study, candidates must meet the following eligibility criteria at
the Screening/Baseline Visit:
Patients with relapsing remitting multiple sclerosis (RRMS) fulfilling the McDonald criteria.
Treatment-naïve patients and patients treated with first-line disease modifying treatment
(DMTs);
Age 18-60 years.
EDSS 1-5.5.
Participants must be able to transport self.
Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion Criteria
Candidates will be excluded from study entry if any of the following exclusion criteria exist at the
Screening/Baseline Visit:
MS relapse or change in DMT within 60 days.
Diagnosis of primary progressive, secondary progressive or progressive relapsing MS.
5
Cancer within five years.
ALAT above 90 U/l, BASP above 210 U/l, gamma-GT above 230 U/l.
Pregnancy or lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified