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 ?

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001253-13-BE

Enrollment

Registered

2017-07-11

Start date

2017-08-23

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.;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.;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)	—

Measure

Time frame

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.;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.;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

Measure	Time frame
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)	—

Countries

Belgium

Contacts

Public ContactStephanie Hostenbach

Universitair Ziekenhuis Brussel

Stephanie.Hostenbach@uzbrussel.be

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 3, 2026