NCT01757691

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 4, 2015

Completed
Last Updated

May 4, 2015

Status Verified

April 1, 2015

Enrollment Period

9 months

First QC Date

December 21, 2012

Results QC Date

April 16, 2015

Last Update Submit

April 16, 2015

Conditions

Acute Demylelinating Optic Neuritis

Keywords

Acute demyelinating optic neuritisOptic neuritis

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and Week 18

Secondary Outcomes (4)

  • Low Contrast Visual Acuity (LCVA)

    Baseline, Week 48

  • Vision Based Quality of Life (QoL) Utility Score

    Baseline, Week 18, Week 48

  • Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS

    Baseline, Week 18, Week 48

  • Number of Particpants With Adverse Events as a Measure of Safety and Tolerability

    Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60

Study Arms (2)

Fingolimod 0.5mg/daily

EXPERIMENTAL

Oral capsule dose was given once daily for 48 weeks

Drug: Fingolimod 0.5mg/daily

Placebo

PLACEBO COMPARATOR

Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48

Drug: Placebo

Interventions

Fingolimod 0.5mg/dailyDRUG
Also known as: FTY, Gilenya
Fingolimod 0.5mg/daily
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

St. Petersburg, Florida, 33713, United States

Location

Novartis Investigative Site

Majadahonda, Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Optic Neuritis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Results Point of Contact

Title
Study Director
Organization
Novartis
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2012

First Posted

December 31, 2012

Study Start

August 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 4, 2015

Results First Posted

May 4, 2015

Record last verified: 2015-04

Locations

US(1)ES(1)