Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)

Phase 2TerminatedNCT01757691

Novartis Pharmaceuticals2 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Demylelinating Optic Neuritis

Interventions

Fingolimod 0.5mg/dailyDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Novartis Investigative Site

St. Petersburg, Florida, United States

Novartis Investigative Site

Majadahonda, Madrid, Spain

Outcomes

Primary Outcomes

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 Outcomes

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

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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.