Fluoxetine in progressive multiple sclerosis: a placebo-controlled randomised trial
| ISRCTN | ISRCTN38456328 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38456328 |
| Secondary identifying numbers | NL583, NTR639 |
- Submission date
- 15/09/2006
- Registration date
- 15/09/2006
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.P. Mostert
Scientific
Scientific
University Medical Center Groningen (UMCG)
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 3614817 / +31 (0)50 3612430 |
|---|---|
| j.p.mostert@neuro.umcg.nl |
Study information
| Study design | Placebo controlled, randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Fluoxetine in progressive multiple sclerosis: a placebo-controlled randomised trial |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Multiple Sclerosis (MS) |
| Intervention | 1. Treatment with fluoxetine 40 mg/day or placebo during 2 years 2. Every 3 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluoxetine |
| Primary outcome measure | 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 study start date | 01/05/2006 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 42 |
| Key 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 |
| Key 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 (SSRIs) 6. Treatment with Monoamine Oxidase (MAO)-inhibitors, oral anticoagulants, 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
PO Box 30001
Groningen
9700 RB
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Hospital/treatment centre
Innovatiefonds University Medical Center Groningen (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 29/07/2013 | 06/01/2021 | Yes | No |
Editorial Notes
07/01/2021: The NTR numbers have been added.
06/01/2021: Publication reference and total final enrolment added.
