MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)

Study Overview
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Brief Summary
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In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.

Official Title
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Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Verum arm receiving Gilenya®
* Drug: Active Comparator receiving Extavia®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of relapsing-remitting multiple sclerosis (RRMS) ability to consent and a written approval First acute ON attack to the fit eye within 30 days before screening Age 18 - 55 years at screening EDSS ≤ 6.0 No MS Attack except for ON in the last 30 days before screening No immunomodulatory therapy for at least three Months (before randomization), or strong immunomodulatory therapy with interferon beta or glatiramer acetate for at least 6 months visus in the affected eye at least 0.1 latency of Conventional VEP in the affected eye = 115 ms or difference> = 15 ms to the opposite side at a Study at least 4 but no more than 6 weeks after Onset of clinical symptoms At least 2 T2 lesions typical of MS in a previous MRI Exclusion Criteria: other MS course than RRMS any condition which could interfere or prevent the MRI study or other investigations known allergy or intolerance, or other contraindication against Gd-DTPA Patients with known contraindications to treatment with fingolimod (Gilenya ®) or interferon beta-1b Extavia ® Competing diseases which could affect visual functions such as diabetic, retinopathy, glaucoma, retinal detachment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fingolimod (Gilenya®)<br>0,5 mg once a day in the morning, oral | Drug: Verum arm receiving Gilenya®<br> <br> |
| Active Comparator: Interferon beta-1b (Extavia®)<br>every second day, s.c. | Drug: Active Comparator receiving Extavia®<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy parameters | Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy parameters | Decrease in the latency of the mVEP from the affected eye at the time points 1, 3 and 12 months in comparison to baseline. Retinal nerve fiber layer thickness and macular volume in OCT, visual contrast sensitivity, visual field, Color vision, visual quality of life, in CMRT lesion load in cMRT , neurotrophic factors and axonal damage markers (neurofilament) and neurotrophins (for example, BDNF) in the serum |  |