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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborators: NeuroCure Clinical Research Center; NeuroCure Clinical Research Center, Charite, Berlin
• Treatments: Fingolimod Hydrochloride; Interferon beta-1b; Interferon-beta; Interferons

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