Does decresaed perfusion of the brain play a role in the reduced function of axons and the clinical disability and fatigue in patients with multiple sclerosis ?

Phase 1

• Conditions: Patients suffering relapsing- remitting multiple sclerosis will be investigated in this study, with an EDSS score less or equal to 4.0. Patients must be older than 18 years old. There must not be any clinical evidence of an MS relpase within the 3 months prior to inclusion.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-001253-13-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-11
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

- Patients with the diagnosis of relapsing-remitting MS, according to the 2010 Revised Mc Donald Criteria
- Age > 18 years
- Written informed consent must be obtained
- EDSS score < or equal to 4
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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- Clinical evidence of MS relapse within 3 months prior to inclusion.
- Known contra-indications for bosentan: liver dysfunction (AST and/or ALT > 3 x ULN), use of cyclosporine A and glibenclamide, allergy
- Pregnancy

Study & Design

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