Condition category
Nervous System Diseases
Date applied
15/09/2006
Date assigned
15/09/2006
Last edited
15/09/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.P. Mostert

ORCID ID

Contact details

University Medical Center Groningen (UMCG)
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 3614817 / +31 (0)50 3612430
j.p.mostert@neuro.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Multiple Sclerosis (MS)

Intervention

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)

Intervention type

Drug

Phase

Not Specified

Drug names

Fluoxetine

Primary outcome measures

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 measures

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

Overall trial start date

01/05/2006

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/05/2006

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Center Groningen (UMCG) (The Netherlands)

Sponsor details

P.O. Box 30001
Groningen
9700 RB
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Innovatiefonds University Medical Center Groningen (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes