progressive multiple sclerosis MedDRA version: 16.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 16.0 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis System Organ Class: 10029205 - Nervous system
Conditions
Interventions
Trade Name: Fluoxetine
Product Name: Fluoxetine
Product Code: fluoxetine
Pharmaceutical Form: Capsule
INN or Proposed INN: Fluoxetine
CAS Number: 59333-67-4
Other descriptive name: N-methyl-3-phenyl
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. Either secondary or primary progressive MS. 3. Age 25-65 years. 4. EDSS at baseline of 3 – 6.5 points inclusive. 5. Disability increased in the preceding year because of steady disease progression. 6. Ability to be compliant with the schedule of protocol assessments. 7. For sexually active female patients with reproductive potential, use of reliable means of contraception. 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation 2.Allergy to fluoxetine 3.Use of fluoxetine 4.Use of other antidepressants, unless they can be stopped for 2 months before starting with the study medication. 5.Contraindication for MRI (relative exclusion criterion because patients who have a contraindication are allowed to participate). 6.Major depression following the DSM-IV 7.Other neurologic, serious psychiatric or systemic disorders that could interfere with the assessments. 8.Use of immunomodulatory or immunosuppressive drugs, except for interferon’s 1a and 1 b or glatiramer (as it has been shown hat these are ineffective in slowing down progression). Patients using other immune drugs can be included if these treatments are stopped before randomization. 9.Participation in another clinical trial 10.Concomitant use of drugs that can cause a serotonin syndrome unless they can be stopped before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •at least a 20 % increase in the timed 25-Foot Walk (T25FW), or •at least a 20 % increase in the 9-Hole Peg Test (9-HPT) = assessment of upper limb function;Secondary Objective: - Changes in global brain atrophy and diffusion tensor imaging. - T2 lesion load. - Proportion of patients without 20 % increase in the T25FW, or 20 % increase in the 9-HPT between weeks 12 and 108. - Significant difference in cognitive function measured by MACFIMS. Optional in some centers (UZ Brussel): •Changes in retinal nerve fiber layer thickness measured by optical coherence tomography between weeks 12 and 108. •Changes in NAA/Cr ratio and glutamate levels in white and gray matter between weeks 12 and 108.;Primary end point(s): Time to confirmed disease progression, defined as either •sustained EDSS increase of 1 point from baseline EDSS if the baseline EDSS was between 3.0 and 5.5 points, or an EDSS increase of 0.5 point if the baseline EDSS was = 5.5 points, or •at least a 20 % increase in the timed 25-Foot Walk (T25FW), or •at least a 20 % increase in the 9-Hole Peg Test (9-HPT) = assessment of upper limb function in each situation the change cannot be attributed to another etiology (e.g. fever, concurrent illness, injury, adverse reactions to concurrent medications, or relapse), and is sustained for = 12 weeks (as assessed during the next visit and at the end of the study). ;Timepoint(s) of evaluation of this end point: Every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Changes in global brain atrophy and diffusion tensor imaging. - T2 lesion load. - Proportion of patients without 20 % increase in the T25FW, or 20 % increase in the 9-HPT between weeks 12 and 108. - Significant difference in cognitive function measured by MACFIMS. (Modified fatigue Impact Scale (MFIS), Beck depression inventory-II (BDI-II) will also be done to control for influences of depression or fatigue on testing) Optional in some centers: - Changes in retinal nerve fiber layer thickness measured by optical coherence tomography between weeks 12 and 108. - Changes in NAA/Cr ratio and glutamate levels in white and gray matter between weeks 12 and 108. ;Timepoint(s) of evaluation of this end point: - MRI: weeks 12 and 108 - Proportion of patients without 20 % increase in the T25FW, or 20 % increase in the 9-HPT between weeks 12 and 108. - Significant difference in cognitive function between week 0, 60 and week 108. Optional in some centers (UZ Brussel): •Changes in retinal nerve fiber layer thickness measured by optical coherence tomography between weeks 12 and 108. •Changes in NAA/Cr ratio and glutamate levels in white and gray matter between weeks 12 and 108. | — |
Countries
Belgium
Outcome results
None listed