Study of efficacy and safety of fingolimod in acute demyelinating optic neuritis
What it found
The trial ended early for another reason (see below).
Reason given: Discontinuation of this study was based on Novartis decision to discontinue development of fingolimod for the treatment of ADON
What was tested
Treatment tested
Placebo or sham
- Placebo
Results by group
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod 0.5mg/Daily | 2 | 0 (0.0%) | |
| Placebo | 0 | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
Baseline and Week 18
Retina scans (OCT)RNFL thinning, to evaluate whether immediate treatment with fingolimod can reduce the axonal loss of retinal neurons following an episode of ADON
Retina scans (OCT)
Other measures (5)
Low Contrast Visual Acuity (LCVA)
Baseline, Week 48
VisionVision Based Quality of Life (QoL) Utility Score
Baseline, Week 18, Week 48
VisionQuality of life (reported by participants)Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS
Baseline, Week 18, Week 48
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60
Safetyassessment of whether immediate treatment with fingolimod can reduce the loss of visual acuity following an episode of ADON
Vision
Who could take part
Optic neuritis · 18 to 50
Inclusion Criteria: * Clinical signs and symptoms of ADON in one eye (loss of vision, pain on movement, impairment of color vision) * First episode of ADON * Able to undergo treatment with IV steroids Exclusion Criteria: * History of any unexplained eye or neurological symptoms lasting longer than 48 hours * Optic neuritis in both eyes * Concomitant condition in either eye, other than optic neuritis * History of heart condition/disease * Patients with uncontrolled diabetes mellitus * Patients with liver conditions/disease * Inability to undergo MRI * Pregnant or nursing women * Women of childbearing potential who are not using highly effective method of birth control * Other protocol-defined inclusion/exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
To evaluate the efficacy and safety of fingolimod 0.5mg versus placebo in patients with suspected acute demyelinating optic neuritis (ADON) receiving standard steroid treatment
Papers
Loading reviews and guidelines…
History
Started
Aug 2013
Main results due
May 2014
Finished
May 2014
Results posted
May 2015
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