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delayed recruitment
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| Name | Class |
|---|---|
| NeuroCure Clinical Research Center, Charite, Berlin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod (Gilenya®) | Experimental | 0,5 mg once a day in the morning, oral |
|
| Interferon beta-1b (Extavia®) | Active Comparator | every second day, s.c. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum arm receiving Gilenya® | Drug |
| ||
| Active Comparator receiving Extavia® |
| 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 |
| 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 |
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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
At least 2 T2 lesions typical of MS in a previous MRI
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olaf Hoffmann, PD Dr. med. | Charite- NeuroCure | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-Universitätsmedizin Berlin | Berlin | Germany | ||||
| Sankt Josefs Krankenhaus Potsdam Neurologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32126977 | Derived | Albert C, Mikolajczak J, Liekfeld A, Piper SK, Scheel M, Zimmermann HG, Nowak C, Dorr J, Bellmann-Strobl J, Chien C, Brandt AU, Paul F, Hoffmann O. Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial. BMC Neurol. 2020 Mar 3;20(1):75. doi: 10.1186/s12883-020-01645-z. |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| Drug |
|
| Potsdam |
| Germany |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |