Clinical Trials Register

Summary
EudraCT Number:	2017-001253-13
Sponsor's Protocol Code Number:	ROCHIMS
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-07-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2017-001253-13

A.3

Full title of the trial

Does cerebral hypoperfusion play a role in reduced axonal metabolism and clinical disability in patients with multiple sclerosis ?

Speelt cerebrale hypoperfusie een rol in het verminderd axonaal metabolisme, de cognitieve achteruitgang en de vermoeidheid in patiënten met mulitple sclerose ?

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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 ?

Speelt de verminderde doorbloeding van de hersenen een rol in een verminderde functie van de axonen, de cognitieve achteruitgang en vermoeiheid in patiënten met multiple sclerose ?

A.3.2

Name or abbreviated title of the trial where available

ROCHIMS (Role of Cerebral Hypoperfusion In Multiple Sclerosis)

A.4.1

Sponsor's protocol code number

ROCHIMS

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	UZ Brussel
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Charcot Foundation
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Actelion Pharmaceuticals
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	UZ Brussel
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitair Ziekenhuis Brussel
B.5.2	Functional name of contact point	Stephanie Hostenbach
B.5.3	Address:
B.5.3.1	Street Address	Laarbeeklaan 101
B.5.3.2	Town/ city	Jette
B.5.3.3	Post code	1090
B.5.3.4	Country	Belgium
B.5.6	E-mail	Stephanie.Hostenbach@uzbrussel.be

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tracleer
D.2.1.1.2	Name of the Marketing Authorisation holder	Actelion Pharmaceuticals Belgium
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

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.

Patiënten die lijden aan relapsing-remitting multiple sclerose zullen geïncludeerd worden in deze studie, met een EDSS score kleiner of gelijk aan 4. Patiënten moeten ouder zijn dan 18 jaar. Er mag geen klinische evidentie zijn voor het doorgemaakt hebben van een MS opstoot 3 maanden voorafgaand aan de inclusie.

E.1.1.1

Medical condition in easily understood language

Patients with relapsing-remitting Multiple Sclerosis, older than 18 years old, who are clinically stable at the moment of inclusion.

RRMS patiënten, ouder dan 18 jaar, die klinisch stabiel zijn op het moment van de inclusie.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

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.

De cerebrale doorbloeding is globaal verlaagd in patiënten met Multiple Sclerose (MS) en kan op zijn beurt bijdragen tot de progressieve axonale degeneratie, cognitieve achteruitgang en vermoeidheid. In deze placebo-gecontrolleerde dubbel-blinde gerandomiseerde studie met de endotheline-1 antagonist bosentan, willen we graag nagaan of het pharmacologische herstel van de cerebrale blood flow (CBF) in patiënten met MS het axonaal metabolism en de klinische achteruitgang kan verbeteren.

E.2.2

Secondary objectives of the trial

Not applicable.

Niet van toepassing.

E.2.3

Trial contains a sub-study

E.3

Principal 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

E.4

Principal 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

E.5 End points

E.5.1

Primary end point(s)

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

E.5.1.1

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)

E.5.2

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.

E.5.2.1

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)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of the trial is defined as the day where the last subject will undergo the last examens written in the protocol.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-08-23

P. End of Trial
P.	End of Trial Status	Ongoing

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