Acute Demylelinating Optic Neuritis
Conditions
Keywords
Acute demyelinating optic neuritis, Optic neuritis
Brief summary
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
Interventions
DRUGFingolimod 0.5mg/daily
DRUGPlacebo
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Due to early termination and low patient enrollment the primary outcome measure was not analyzed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low Contrast Visual Acuity (LCVA) | Baseline, Week 48 | Due to early termination and low patient enrollment this trial was not powered for efficacy |
| Vision Based Quality of Life (QoL) Utility Score | Baseline, Week 18, Week 48 | Due to early termination and low patient enrollment this trial was not powered for efficacy |
| Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS | Baseline, Week 18, Week 48 | Due to early termination and low patient enrollment this trial was not powered for efficacy |
| Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 | Number of particpants with Adverse events as a measure of safety and tolerability |
Countries
Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fingolimod 0.5mg/Daily Oral capsule dose was given once daily for 48 weeks | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative problems | 2 | 0 |
Baseline characteristics
| Characteristic | Fingolimod 0.5mg/Daily |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 2 | 0 / 0 |
| serious Total, serious adverse events | 0 / 2 | 0 / 0 |
Outcome results
Primary
Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
Due to early termination and low patient enrollment the primary outcome measure was not analyzed
Time frame: Baseline and Week 18
Secondary
Low Contrast Visual Acuity (LCVA)
Due to early termination and low patient enrollment this trial was not powered for efficacy
Time frame: Baseline, Week 48
Secondary
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Number of particpants with Adverse events as a measure of safety and tolerability
Time frame: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60
Population: Safety population consited of all patients who received at least one dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fingolimod 0.5mg/Daily | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Adverse Events (AE) | 1 Participants |
| Fingolimod 0.5mg/Daily | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Death | 0 Participants |
| Fingolimod 0.5mg/Daily | Number of Particpants With Adverse Events as a Measure of Safety and Tolerability | Non -Fatal Seriuos Aderse Event (SAE) | 0 Participants |
Secondary
Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS
Due to early termination and low patient enrollment this trial was not powered for efficacy
Time frame: Baseline, Week 18, Week 48
Secondary
Vision Based Quality of Life (QoL) Utility Score
Due to early termination and low patient enrollment this trial was not powered for efficacy
Time frame: Baseline, Week 18, Week 48