Acute Demylelinating Optic NeuritisPhase 2NCT01757691
Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
A Phase 2 study testing Fingolimod 0.5mg/daily in people with Acute Demylelinating Optic Neuritis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Demylelinating Optic Neuritis
- What is being tested?
- Fingolimod 0.5mg/daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2013to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Novartis Investigative Site
St. Petersburg, Florida, 33713
About this study
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
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
- Conditions
- Acute Demylelinating Optic Neuritis
- Being tested
- Fingolimod 0.5mg/daily, Placebo
- Keywords
- Acute demyelinating optic neuritis, Optic neuritis
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingolimod 0.5mg/dailyDrug
Also called FTY, Gilenya
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod 0.5mg/daily | Experimental | Oral capsule dose was given once daily for 48 weeks Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and Week 18
Secondary outcomes (4)
Low Contrast Visual Acuity (LCVA)
Due to early termination and low patient enrollment this trial was not powered for efficacy
Measured: 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
Measured: 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
Measured: 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
Measured: Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startAug 2013
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Discontinuation of this study was based on Novartis decision to discontinue development of fingolimod for the treatment of ADON
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Demylelinating Optic NeuritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757691
- Sponsor's protocol ID
- CFTY720D2402
- Other IDs
- 2012-002968-27
- Status last verified
- Apr 2015
- First submitted
- 21 Dec 2012
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01757691
- Acronym / sponsor ID
- CFTY720D2402
- Conditions
- Acute Demylelinating Optic Neuritis
- Keywords
- Acute demyelinating optic neuritis, Optic neuritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinuation of this study was based on Novartis decision to discontinue development of fingolimod for the treatment of ADON
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 Dec 2012 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod 0.5mg/daily | Experimental | Drug: Fingolimod 0.5mg/dailyOral capsule dose was given once daily for 48 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPatients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fingolimod 0.5mg/dailyAlso: FTY, Gilenya | Drug | Fingolimod 0.5mg/daily |
| Placebo | Drug | Placebo |
Primary outcome
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
Due to early termination and low patient enrollment the primary outcome measure was not analyzed
4 secondary outcomes
Low Contrast Visual Acuity (LCVA)
Time frame: Baseline, Week 48
Vision Based Quality of Life (QoL) Utility Score
Time frame: Baseline, Week 18, Week 48
Proportion of Paatients Converting to Either 2005 or 2010 McDonald MS or to CDMS
Time frame: Baseline, Week 18, Week 48
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fingolimod 0.5mg/daily in people with Acute Demylelinating Optic Neuritis, run by Novartis Pharmaceuticals at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.