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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004787-30-DE

Enrollment

Registered

2012-07-13

Start date

2012-10-26

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis or clinically isolated syndrom

Interventions

Trade Name: Gilenya® Product Name: Gilenya® Product Code: Gilenya® Pharmaceutical Form: Capsule, hard INN or Proposed INN: Fingolimod CAS Number: 162359-55-9 Current Sponsor code: Gilenya Other descr

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess whether an early therapy with Fingolimod (Gilenya®) after Optic neuritis (ON) leads to a more favourable visual outcome after 6 months compared to a therapy with Interferon beta-1b (Extavia®).;Secondary Objective: To asses the effect of a 6 months treatment with Fingolimod on different secondary outcomes regarding amongts others visual system etc. ;Primary end point(s): Latency of multifocal VEP (mVEP) of the affected eye after 6 months therapy compared to baseline ;Timepoint(s) of evaluation of this end point: 6 months after baseline	—

Measure

Time frame

Main Objective: To assess whether an early therapy with Fingolimod (Gilenya®) after Optic neuritis (ON) leads to a more favourable visual outcome after 6 months compared to a therapy with Interferon beta-1b (Extavia®).;Secondary Objective: To asses the effect of a 6 months treatment with Fingolimod on different secondary outcomes regarding amongts others visual system etc. ;Primary end point(s): Latency of multifocal VEP (mVEP) of the affected eye after 6 months therapy compared to baseline ;Timepoint(s) of evaluation of this end point: 6 months after baseline

—

Secondary

Measure	Time frame
Secondary end point(s): Different secondary outcomes regarding visual system etc. ;Timepoint(s) of evaluation of this end point: 3, 6 and 12 months after baseline	—

Countries

Germany

Contacts

Public ContactNeuroCure

Charite Universitaetsmedizin Berlin

friedemann.paul@charite.de+4930450539705

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026