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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 March 2020 |
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Main ID: |
EUCTR2014-000296-12-FI |
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Date of registration:
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28/02/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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N/A
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Scientific title:
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N/A |
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Date of first enrolment:
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15/04/2014 |
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Target sample size:
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10 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-000296-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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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: no
Placebo: no
Other: yes
Other specify the comparator: same patient before and after treatment
Number of treatment arms in the trial: 1
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Finland
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Contacts
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Name:
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Turku University Hospital
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Address:
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Kiinamyllynkatu 4- 8
Turku
Finland |
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Telephone:
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Email:
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laura.airas@tyks.fi |
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Affiliation:
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Turku University Hospital |
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Name:
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Turku University Hospital
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Address:
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Kiinamyllynkatu 4- 8
Turku
Finland |
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Telephone:
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Email:
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laura.airas@tyks.fi |
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Affiliation:
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Turku University Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Multiple sclerosis
MedDRA version: 16.1
Level: PT
Classification code 10028245
Term: Multiple sclerosis
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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Trade Name: Gilenya
Product Name: Fingolimodi
Pharmaceutical Form: Capsule, hard
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Primary Outcome(s)
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Secondary Objective: none
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Main Objective: To evaluate weather fingolimodi-treatment has an effect on microglial activation
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Primary end point(s):
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Secondary Outcome(s)
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Secondary end point(s): none
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Source(s) of Monetary Support
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Novartis
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Ethics review
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Status: Approved
Approval date: 15/04/2014
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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