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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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27 January 2025 |
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Main ID: |
EUCTR2010-023996-25-BE |
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Date of registration:
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25/11/2010 |
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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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The effect of fluoxetine and 5-HT4 serotonin receptor agonists on cerebral axonal energy metabolism and glutamate levels in multiple sclerosis.
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Scientific title:
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The effect of fluoxetine and 5-HT4 serotonin receptor agonists on cerebral axonal energy metabolism and glutamate levels in multiple sclerosis. |
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Date of first enrolment:
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21/12/2010 |
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Target sample size:
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32 |
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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:2010-023996-25 |
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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: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no
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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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Belgium
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
- age of 18-60 years
- EDSS of <7
- no corticosteroid treatment within the 3 months prior to the study
- In women of childbearing age, adequate contraception should be guaranteed.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- ECG with QT-lengthening
- Use of medication that influences the QT interval
- Diabetes mellitus
- pregnancy and breastfeeding
- Contraindication for MRI
- Use of antidepressants, MAO inhibitors, serotonin agonists
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 (both relapsing remitting and progressive forms)
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Intervention(s)
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Product Name: fluoxetine
Pharmaceutical Form: Coated tablet
CAS Number: 54910-89-3
Other descriptive name: FLUOXETINE
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 20-40
Product Name: Cisapride
Pharmaceutical Form: Coated tablet
INN or Proposed INN: CISAPRIDE
CAS Number: 81098604
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 10-20
Product Name: Prucalopride
Pharmaceutical Form: Coated tablet
INN or Proposed INN: PRUCALOPRIDE
CAS Number: 179474818
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 1-2
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Primary Outcome(s)
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Main Objective: To study the energy metabolism of the astrocytes in multiple sclerosis. We will investigate whether elevation of cAMP signaling (by fluoxetine, cisapride and prucalopride) in astrocytes of persons with MS is able to restore axonal metabolism and reduce glutamate levels in normal appearing white matter and gray matter.
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Primary end point(s): - MRS: NAA and glutamaat
- EDSS
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Secondary Objective:
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 02/12/2010
Contact:
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Results
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Results available:
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Date Completed:
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