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

July 28, 2021 updated by: Friedemann Paul, Charite University, Berlin, Germany

Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charite-Universitatsmedizin Berlin
      • Potsdam, Germany
        • Sankt Josefs Krankenhaus Potsdam Neurologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fingolimod (Gilenya®)
0,5 mg once a day in the morning, oral
Drug: Verum arm receiving Gilenya®
ACTIVE_COMPARATOR: Interferon beta-1b (Extavia®)
every second day, s.c.
Drug: Active Comparator receiving Extavia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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

Outcome Measure
Measure Description
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

NeuroCure Clinical Research Center, Charite, Berlin

Investigators

  • Study Director: Olaf Hoffmann, PD Dr. med., Charite- NeuroCure

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

April 1, 2016

Study Completion (ACTUAL)

April 1, 2016

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (ESTIMATE)

July 24, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOVING

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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