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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fingolimod (Gilenya®)

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

Group Type EXPERIMENTAL

Verum arm receiving Gilenya®

Intervention Type DRUG

Interferon beta-1b (Extavia®)

every second day, s.c.

Group Type ACTIVE_COMPARATOR

Active Comparator receiving Extavia®

Intervention Type DRUG

Interventions

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Verum arm receiving Gilenya®

Intervention Type DRUG

Active Comparator receiving Extavia®

Intervention Type DRUG

Eligibility Criteria

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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

* = 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No