Acute Demylelinating Optic Neuritis Clinical Trial
Official title:
A 48-week, Double-blind, Randomized, Multi-center, Parallel-group Study Comparing Structural Changes in the Retina and Evolution of Visual Function After Immediate Versus Delayed Treatment With Fingolimod in Patients With Acute Demyelinating Optic Neuritis
| Verified date | April 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 2 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Novartis Investigative Site | Majadahonda | Madrid |
| United States | Novartis Investigative Site | St. Petersburg | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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 | Baseline and Week 18 | No |
| Secondary | Low Contrast Visual Acuity (LCVA) | Due to early termination and low patient enrollment this trial was not powered for efficacy | Baseline, Week 48 | No |
| Secondary | Vision Based Quality of Life (QoL) Utility Score | Due to early termination and low patient enrollment this trial was not powered for efficacy | Baseline, Week 18, Week 48 | No |
| 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 | Baseline, Week 18, Week 48 | No |
| 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 | Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 | Yes |