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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01757691
First received: December 21, 2012
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Acute Demylelinating Optic Neuritis
Drug: Fingolimod 0.5mg/daily
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Low contrast visual acuity [ Time Frame: Baseline, Week 48 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 2
Study Start Date: August 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod 0.5mg/daily Drug: Fingolimod 0.5mg/daily
Other Name: FTY, Gilenya
Placebo Comparator: Placebo
Patients will receive placebo from Weeks 0-18, and will then change over to fingolimod 0.5/mg from Weeks 18-48
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01757691

Locations
United States, Florida
Novartis Investigative Site
St. Petersburg, Florida, United States, 33713
Spain
Novartis Investigative Site
Majadanonda, Madrid, Spain, 28220
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01757691     History of Changes
Other Study ID Numbers: CFTY720D2402, 2012-002968-27
Study First Received: December 21, 2012
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Acute demyelinating optic neuritis
Optic neuritis

Additional relevant MeSH terms:
Optic Neuritis
Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Fingolimod
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014