A double-blind, randomized, mulicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 1.25 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis

Phase 3

Completed

• Conditions: Primair Progressieve Multiple Sclerose; 10003816; 10012303

• Registration Number: NL-OMON39840
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 57

Inclusion Criteria

* male/female, 25 through 65 years of age inclusive
* diagnosis of primary progressive multiple sclerosis (one year of disease progression plus
at least two of the following: a) positive brain MRI, b) positive spinal cord MRI, c) positive CSF).
* time since first reported symptoms between 2 and 10 years
* documented evidence of clinical disability progression in the 2 years prior to Screening
* EDSS score of 3.5-6.0 inclusive
* pyramidal functional system score of 2 or more
* 25*TWT less than 30 seconds

Exclusion Criteria

* history of MS attack/relapse
* progressive disabling neurological disorder, other than PPMS
* presence of cervical spinal cord compression (on Screening MRI)
* relevant history of vitamin B12 deficit
* history of chronic active disease of the immune system other than MS
* diagnosis of macular edema
* unable to undergo MRI scans

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>EFFICACY<br /><br>25'TWT, EDSS, 9-HPT</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety and tolerability of FTY720; MRI parameters; patient reported outcomes;<br /><br>pharmacokinetics; pk/pd relationship </p><br>