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

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Active Comparator receiving Extavia®; Drug: Verum arm receiving Gilenya®

• Registration Number: NCT01647880
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-07-23
• Study First Posted: 2012-07-24
• Study Start: 2013-07
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferon beta-1b (Extavia®)	Active Comparator receiving Extavia®	every second day, s.c.
Fingolimod (Gilenya®)	Verum arm receiving Gilenya®	0,5 mg once a day in the morning, oral

Primary Outcome Measures

Name	Time	Method
Efficacy parameters		Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Charité-Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Sankt Josefs Krankenhaus Potsdam Neurologie; 🇩🇪 Potsdam, Germany