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

Phase 2

Terminated

• Conditions: Acute Demylelinating Optic Neuritis
• Interventions: Drug: Fingolimod 0.5mg/daily; Drug: Placebo

• Registration Number: NCT01757691
• Lead Sponsor: Novartis Pharmaceuticals

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2012-12-21
• Study First Posted: 2012-12-31
• Study Start: 2013-08
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-04
• Results First Submitted: 2015-04-16
• Results First Submitted QC: 2015-04-16
• Last Update Submitted: 2015-04-16
• Results First Posted: 2015-05-04
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fingolimod 0.5mg/daily	Fingolimod 0.5mg/daily	Oral capsule dose was given once daily for 48 weeks
Placebo	Placebo	Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Majadahonda, Madrid, Spain