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 ?

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2017-001253-13-BE
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: UZ Brussel
• Public title: 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 ?
• Scientific title: Does cerebral hypoperfusion play a role in reduced axonal metabolism and clinical disability in patients with multiple sclerosis ? - ROCHIMS (Role of Cerebral Hypoperfusion In Multiple Sclerosis)
• Date of first enrolment: 23/08/2017
• Target sample size: 30
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-001253-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Belgium

Contacts

• Name: Stephanie Hostenbach
• Affiliation: Universitair Ziekenhuis Brussel

• Name: Stephanie Hostenbach
• Affiliation: Universitair Ziekenhuis Brussel

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

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.

Intervention(s)

Trade Name: Tracleer
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: Cerebral perfusion is globally decreased in patients with Multiple Sclerosis (MS) and might contribute to progressive axonal degeneration, cognitive decline and fatigue. In this placebo-controlled, double-blind, randomized trial with the endothelin-1 antagonist bosentan, we want to explore whether pharmacological restoration of cerebral blood flow (CBF) in patients with MS can improve axonal metabolism and clinical disability.

Timepoint(s) of evaluation of this end point: Before the start of the study (day 0).
At the end of the study (this is at day 28 +/- 2 days)

Secondary Objective: Not applicable.

Primary end point(s): N-acetyl aspartate (NAA) levels after restoring the cerebral blood flow (CBF) with the endothelin-1 antagonist.

Secondary Outcome(s)

Secondary end point(s): - Effects on the clinical disability and fatigue in MS patients
- Effects on biomarkers of multiple sclerosis (serum neurofilament light chain) wich can be used as a marker of axonal damage.

Timepoint(s) of evaluation of this end point: Before the start of the study (day 0).
At the end of the study (this is at day 28 +/- 2 days)

Secondary ID(s)

ROCHIMS

Source(s) of Monetary Support

Actelion Pharmaceuticals

UZ Brussel

Charcot Foundation