Back to resultsFingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
Primary Purpose
Acute Demylelinating Optic Neuritis
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fingolimod 0.5mg/daily
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Demylelinating Optic Neuritis focused on measuring Acute demyelinating optic neuritis, Optic neuritis
Eligibility Criteria
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fingolimod 0.5mg/daily
Placebo
Arm Description
Oral capsule dose was given once daily for 48 weeks
Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Low Contrast Visual Acuity (LCVA)
Due to early termination and low patient enrollment this trial was not powered for efficacy
Vision Based Quality of Life (QoL) Utility Score
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
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
Number of particpants with Adverse events as a measure of safety and tolerability
Full Information
NCT ID
NCT01757691
First Posted
December 21, 2012
Last Updated
April 16, 2015
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01757691
Brief Title
Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Discontinuation of this study was based on Novartis decision to discontinue development of fingolimod for the treatment of ADON
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Demylelinating Optic Neuritis
Keywords
Acute demyelinating optic neuritis, Optic neuritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fingolimod 0.5mg/daily
Arm Type
Experimental
Arm Description
Oral capsule dose was given once daily for 48 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
Intervention Type
Drug
Intervention Name(s)
Fingolimod 0.5mg/daily
Other Intervention Name(s)
FTY, Gilenya
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Retinal Nerve Fiber Layer (RNFL) Thinning in Patients Treated With Fingolimod 0.5mg/Day, Relative to Patients Treated With Placebo
Description
Due to early termination and low patient enrollment the primary outcome measure was not analyzed
Time Frame
Baseline and Week 18
Secondary Outcome Measure Information:
Title
Low Contrast Visual Acuity (LCVA)
Description
Due to early termination and low patient enrollment this trial was not powered for efficacy
Time Frame
Baseline, Week 48
Title
Vision Based Quality of Life (QoL) Utility Score
Description
Due to early termination and low patient enrollment this trial was not powered for efficacy
Time Frame
Baseline, Week 18, Week 48
Title
Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS
Description
Due to early termination and low patient enrollment this trial was not powered for efficacy
Time Frame
Baseline, Week 18, Week 48
Title
Number of Particpants With Adverse Events as a Measure of Safety and Tolerability
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Facility Name
Novartis Investigative Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
12. IPD Sharing Statement
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Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
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