A randomized double blind, placebo-controlled study of fluoxetine in progressive multiple sclerosis (FLUOX-PMS)

Phase 3

Conditions: progressive multiple sclerosis
slow degradation of the insulating layer of the nerve fibers
10003816
10012303

Registration Number: NL-OMON37668

Lead Sponsor: Prof. dr. J. de Keyser, Neurologie, UZ Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1.Signed written informed consent.
2.Either secondary or primary progressive MS according to the 2005 Revised McDonald criteria.
3.Age 25-65 years.
4.EDSS at baseline of 3 - 6.5 points inclusive. Disability increased in the preceding year because of steady disease progression unrelated to relapses for at least 12 months.
5.Ability to be compliant with the schedule of protocol assessments.
6.For sexually active female patients with reproductive potential, use of reliable means of contraception.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>timed 25-Foot Walk (T25FW),<br /><br>9-Hole Peg Test (9-HPT)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>MRI: diffusion tensor imaging, global brain atrophy and T2 lesion load.<br /><br>Cognition: MACFIMS, BDI, MFIS, HAI<br /><br>Ambulation: Ambulation Index</p><br>