Modification of the visual outcome after optic neuritis in CIS or MS by Gilenya®

Phase 1

• Conditions: Multiple sclerosis or clinically isolated syndrom; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004787-30-DE
• Lead Sponsor: Charite Universitaetsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-13
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• relapsing-remitting Multiple sclerosis (MS) or clinically isolated syndrom
• Informed consent
• First acute optic neuritis (ON) bout on qualifying eye within 30 days bevore screening
• Age 18 - 55 years at screening
• EDSS = 6,0
• No MS bout except ON in the last 30 days before secreening
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 88
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Know contraindications againts therapy with Fingolimod (Gilenya®) or Interferon beta-1b Extavia®
• pregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified