NCT01647880

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 multiple-sclerosis

Timeline
Completed

Started Jul 2013

Typical duration for phase_2 multiple-sclerosis

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

2.8 years

First QC Date

July 23, 2012

Last Update Submit

July 28, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Efficacy parameters

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

Secondary Outcomes (1)

  • Efficacy parameters

Study Arms (2)

Fingolimod (Gilenya®)

EXPERIMENTAL

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

Drug: Verum arm receiving Gilenya®

Interferon beta-1b (Extavia®)

ACTIVE COMPARATOR

every second day, s.c.

Drug: Active Comparator receiving Extavia®

Interventions

Verum arm receiving Gilenya®DRUG
Fingolimod (Gilenya®)
Active Comparator receiving Extavia®DRUG
Interferon beta-1b (Extavia®)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité-Universitätsmedizin Berlin

Berlin, Germany

Location

Sankt Josefs Krankenhaus Potsdam Neurologie

Potsdam, Germany

Location

Related Publications (1)

  • 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.

    PMID: 32126977DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Olaf Hoffmann, PD Dr. med.

    Charite- NeuroCure

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Sponsor Deputy

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 24, 2012

Study Start

July 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(2)