MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by G
Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis
What it found
The trial ended early for another reason (see below).
Reason given: delayed recruitment
What was tested
Treatment tested
- Verum arm receiving Gilenya®
Compared with
- Active Comparator receiving Extavia®
What it measured
Main measures
Efficacy parameters
Myelin repair
Other measures (1)
Efficacy parameters
MRI lesionsBlood or spinal fluid markersMyelin repairRetina scans (OCT)VisionQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jul 2013
Main results due
Apr 2016
Finished
Apr 2016