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| [ Print-friendly version ] |
| Fluoxetine in progressive multiple sclerosis: a placebo-controlled randomised trial |
| ISRCTN | ISRCTN38456328 |
| ClinicalTrials.gov identifier | |
| Public title | Fluoxetine in progressive multiple sclerosis: a placebo-controlled randomised trial |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis | Fluoxetine has in animals and cell cultures neuroprotective properties. We test whether fluoxetine is able to reduce progression in patients with Multiple Sclerosis (MS). |
| Ethics approval | Ethics approval received from the local medical ethics committee |
| Study design | Placebo controlled, randomised trial |
| Countries of recruitment | The Netherlands |
| Disease/condition/study domain | Multiple Sclerosis (MS) |
| Participants - inclusion criteria |
1. Written informed consent
2. Age 18 to 65 3. MS according to the McDonald criteria or primary progressive MS according to the Thompson criteria 4. Expanded Disability Status Scale (EDSS) 3.0 to 6.5 inclusive 5. Documented progression in the last two years unrelated to clinical exacerbations in the last two years |
| Participants - exclusion criteria |
1. Contra-indication Magnetic Resonance Imaging (MRI) (e.g., metal, claustrophobia)
2. Women of childbearing potential, who are not using a medically accepted safe method of contraception 3. Pregnancy or women who are lactating 4. Moderate to severe depression measured as a score of more than 18 on the Beck Depression Inventory (BDI) 5. Treatment with Selective Serotonin Reuptake Inhibitors (SSRI's) 6. Treatment with Monoamine Oxidase (MAO)-inhibitors, oral anticoagulantia, Serotonin (5-HT) agonists and/or lithium 7. Treatment with interferon ß, glatiramer acetate, plasmapheresis, natalizumab, other immunomodulatory drugs, or immunosuppressive drugs including azathioprine, cyclophosphamide and methotrexate, within six months of week zero 8. Treatment with corticosteroids within three months of week zero 9. Renal failure 10. Neurological disorder other than MS, acute or chronic infection, malignant neoplasm or metastasis, cardiovascular disorder or pulmonary disorder, severe intercurrent systemic disease, or any other disease that interferes with the assessments |
| Anticipated start date | 01/05/2006 |
| Anticipated end date | 01/05/2009 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | 60 |
| Interventions |
1. Treatment with fluoxetine 40 mg/day or placebo during two years
2. Every three months clinical evaluation (EDSS, Multiple Sclerosis Functional Composite [MSFC], Ambulatory Index [AI]) 3. Yearly cerebral MRI 4. Yearly questionnaires (Guys Neurological Disability Scale, BDI, Short Form [SF-36] health survey) |
| Primary outcome measure(s) |
Number of patients with progression in two years. Progression is defined as:
1. Persistent (two or more follow-up assessments) worsening of EDSS with 1.0 point with basis EDSS 3.0 to 5.0 or persistent (two or more follow-up assessments) worsening of EDSS with 0.5 with basis EDSS 5.5 to 6.5 2. Or persistent (two or more follow-up assessments) worsening of 9-Hole Peg Test (9-HPT) with 20% compared to baseline measurement 3. Or persistent (two or more follow-up assessments) worsening of the AI of one point with a basis AI between two and six |
| Secondary outcome measure(s) |
1. Change in the following MRI measurements:
a. T2 lesion volume b. T1 lesion volume (black holes) c. Brain atrophy d. N-Acetyl Aspartate (NAA) e. Apparent Diffusion Co-efficient (ADC) and Fractional Anisotropy (FA) histogram values 2. Change in EDSS, MSFC, SF-36, Guys Neurological Disability Scale, BDI, Family Intrusiveness Scale (FIS) 3. Time (in months) to progression |
| Sources of funding | Innovatiefonds University Medical Center Groningen (The Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr J.P. Mostert |
| Address |
University Medical Center Groningen (UMCG)
P.O. Box 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Tel | +31 (0)50 3614817 / +31 (0)50 3612430 |
| j.p.mostert@neuro.umcg.nl | |
| Sponsor | University Medical Center Groningen (UMCG) (The Netherlands) |
| Address | P.O. Box 30001 |
| City/town | Groningen |
| Zip/Postcode | 9700 RB |
| Country | Netherlands |
| Date applied | 15/09/2006 |
| Last edited | 15/09/2006 |
| Date ISRCTN assigned | 15/09/2006 |
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