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

Primary Purpose

Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Verum arm receiving Gilenya®
Active Comparator receiving Extavia®
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Charité-Universitätsmedizin Berlin
  • Sankt Josefs Krankenhaus Potsdam Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fingolimod (Gilenya®)

Interferon beta-1b (Extavia®)

Arm Description

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

every second day, s.c.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
July 23, 2012
Last Updated
July 28, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT01647880
Brief Title
MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)
Acronym
MOVING
Official Title
Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
delayed recruitment
Study Start Date
July 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
NeuroCure Clinical Research Center, Charite, Berlin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fingolimod (Gilenya®)
Arm Type
Experimental
Arm Description
0,5 mg once a day in the morning, oral
Arm Title
Interferon beta-1b (Extavia®)
Arm Type
Active Comparator
Arm Description
every second day, s.c.
Intervention Type
Drug
Intervention Name(s)
Verum arm receiving Gilenya®
Intervention Type
Drug
Intervention Name(s)
Active Comparator receiving Extavia®
Primary Outcome Measure Information:
Title
Efficacy parameters
Description
Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline
Secondary Outcome Measure Information:
Title
Efficacy parameters
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Hoffmann, PD Dr. med.
Organizational Affiliation
Charite- NeuroCure
Official's Role
Study Director
Facility Information:
Facility Name
Charité-Universitätsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Sankt Josefs Krankenhaus Potsdam Neurologie
City
Potsdam
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32126977
Citation
Albert C, Mikolajczak J, Liekfeld A, Piper SK, Scheel M, Zimmermann HG, Nowak C, Dorr J, Bellmann-Strobl J, Chien C, Brandt AU, Paul F, Hoffmann O. Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial. BMC Neurol. 2020 Mar 3;20(1):75. doi: 10.1186/s12883-020-01645-z.
Results Reference
derived

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

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