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

Charité University Medicine Berlin

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Multiple Sclerosis

Treatments: Drug: Active Comparator receiving Extavia®; Drug: Verum arm receiving Gilenya®

Study type: Interventional

Funder types: Other

Identifiers

NCT01647880

MOVING

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Fingolimod (Gilenya®)

Experimental group

Description:

0,5 mg once a day in the morning, oral

Treatment:

Drug: Verum arm receiving Gilenya®

Interferon beta-1b (Extavia®)

Active Comparator group

Description:

every second day, s.c.

Treatment:

Drug: Active Comparator receiving Extavia®