The effect of fluoxetine and 5-HT4 serotonin receptor agonists on cerebral axonal energy metabolism and glutamate levels in multiple sclerosis.
- Conditions
- Multiple sclerosis (both relapsing remitting and progressive forms)
- Registration Number
- EUCTR2010-023996-25-BE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 32
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. ;Secondary Objective: ;Primary end point(s): - MRS: NAA and glutamaat<br>- EDSS
- Secondary Outcome Measures
Name Time Method