Clinical Trial: Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Fingol

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

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo [ Time Frame: Baseline and Week 18 ]

Due to early termination and low patient enrollment the primary outcome measure was not analyzed


Original Primary Outcome: Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo [ Time Frame: Baseline and Week 18 ]

Primary endpoint is the difference between the OCT determined retinal nerve fiber layer thickness (RNFLT) of the affected eye at the week 18 post-baseline visit and the RNFLT of the fellow eye at baseline


Current Secondary Outcome:

  • Low Contrast Visual Acuity (LCVA) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 ]
    Number of particpants with Adverse events as a measure of safety and tolerability


Original Secondary Outcome:

  • Low contrast visual acuity [ Time Frame: Baseline, Week 48 ]
    The impact [on visual acuity], of immediate treatment with fingolimod 0.5mg/daily (48 weeks of continuous treatment) will be compared with that of delayed treatment with fingolimod 0.5mg/daily (18 weeks of placebo then 30 weeks of fingolimod), through testing with low contrast Sloan letter charts at 1.25, and 2.5% contrast levels
  • Vision based quality of life (QoL) [ Time Frame: Baseline, Week 18, Week 48 ]
    The impact [on vision based quality of life], of immediate treatment with fingolimod 0.5mg/daily (48 weeks of continuous treatment) will be compared with that of delayed treatment with fingolimod 0.5mg/daily (18 weeks of placebo then 30 weeks of fingolimod), through administration of the NEI-VFQ-25 Form
  • Conversion to either 2005 or 2010 McDonald MS or to CDMS [ Time Frame: Baseline, Week 18, Week 48 ]
    The impact [on conversion to either 2005 or 2010 McDonald MS or to CDMS], of immediate treatment with fingolimod 0.5mg/daily (48 weeks of continuous treatment) will be compared with that of delayed treatment with fingolimod 0.5mg/daily (18 weeks of placebo then 30 weeks of fingolimod), through MRI testing and MS relapse assessment
  • Safety and tolerability of fingolimod in patients with ADON [ Time Frame: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 ]
    Safety and tolerability of fingolimod in patients with ADON will be assessed at each study visit through: physical exam, vital signs, blood sampling, urinalysis, pregnancy testing, ECG, detailed neurological exam. including EDSS. First dose monitoring will be conducted for all patients at baseline, Week 18 and re-starts after dosage interruptions, per the Protocol.


Information By: Novartis

Dates:
Date Received: December 21, 2012
Date Started: August 2013
Date Completion:
Last Updated: April 16, 2015
Last Verified: April 2015