Multiple Sclerosis
Conditions
Brief summary
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.
Interventions
DRUGVerum arm receiving Gilenya®
DRUGActive Comparator receiving Extavia®
Sponsors
NeuroCure Clinical Research Center, Charite, Berlin
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy parameters | — | Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed