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

Phase 2/3 Terminated 15 enrolled Charite University, Berlin, Germany NeuroCure Clinical Research Center, Charite, Berlin · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2013-07
Primary completion: 2016-04
Completion: 2016-04

Outcome

Met primary endpoint

Stopped (Enrollment): “delayed recruitment”

paper primary endpoint revealed a significantly larger reduction of mfVEP latency at 6 months compared to baseline with fingolimod treatment PMID 32126977 ↗

paper (p < 0.001 for interaction). PMID 32126977 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fingolimod	Small molecule	0.5 mg	Oral
Comparator	Interferon beta-1b	Protein / enzyme biologic	250 ug	Subcutaneous