Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosis

• Register: EUCTR
• Last refreshed on: 12 January 2015
• Main ID: EUCTR2014-001012-19-NL
• Date of registration: 15/10/2014
• Prospective Registration: Yes
• Primary sponsor: VU University Medical Center
• Public title: Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosis
• Scientific title: Effects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis - Effect of fingolimod on brain and cognition
• Date of first enrolment: 17/12/2014
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-001012-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: Secretary
• Affiliation: VU University Medical Center - Dept. of Anatomy and Neurosciences

• Name: Secretary
• Affiliation: VU University Medical Center - Dept. of Anatomy and Neurosciences

Key inclusion & exclusion criteria

Inclusion criteria:
- Subjects should be between 18 and 65 years of age
- Subjects should meet the safety criteria to undergo MRI examination
- Patients should be diagnosed with RRMS
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 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
- Presence or history of psychiatric or neurological disease (for patients: neurological disease other than MS)
- Presence or history of drug abuse
- For patients: relapse or steroid treatment less than four weeks prior to examination
- Insufficient visual acuity and motor skills to perform the fMRI task


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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing-remitting (RR) multiple sclerosis (MS)

Intervention(s)

Trade Name: Gilenya
Pharmaceutical Form: Capsule
INN or Proposed INN: fingolimod
CAS Number: 162359-56-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: Interferon Beta
Pharmaceutical Form:
INN or Proposed INN: interferon beta-1b
CAS Number: 145155-23-3
Other descriptive name: INTERFERON BETA-1B
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0-0.25
INN or Proposed INN: interferon beta-1a
CAS Number: 220581-49-7
Other descriptive name: INTERFERON BETA-1A
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0-0.044

Trade Name: Copaxone
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Secondary Objective: 1. Does fingolimod affect functional connectivity as measured by resting-state fMRI?
2. Does fingolimod affect brain activation patterns and task performance during an information-processing task (task-related fMRI)?
3. Does fingolimod affect physical disability and cognitive decline? Is this effect measurable through functional adaptation?
4. Does fingolimod limit structural brain damage over time?
5. Does fingolimod enhance functional brain adaptation over time?

Main Objective: To investigate whether the disproportionally strong clinical effects of fingolimod in RRMS can be explained by enhanced functional brain adaptation and whether enhanced functional adaptation is sustained over time

Primary end point(s): - Improved neuropsychological test performance
- Changed functional MRI/connectivity
- Improved cognitive well being

Timepoint(s) of evaluation of this end point: Six and eighteen months after baseline

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: NA

Secondary end point(s): NA

Secondary ID(s)

tba

CFTY720DNL02T

Source(s) of Monetary Support

Novartis Pharma