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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002968-27 | EudraCT Number |
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Discontinuation of this study was based on Novartis decision to discontinue development of fingolimod for the treatment of ADON
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod 0.5mg/daily | Experimental | Oral capsule dose was given once daily for 48 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod 0.5mg/daily | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Low Contrast Visual Acuity (LCVA) | Due to early termination and low patient enrollment this trial was not powered for efficacy | Baseline, Week 48 |
| Vision Based Quality of Life (QoL) Utility Score |
Not provided
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | St. Petersburg | Florida | 33713 | United States | ||
| Novartis Investigative Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod 0.5mg/Daily | Oral capsule dose was given once daily for 48 weeks |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod 0.5mg/Daily | Oral capsule dose was given once daily for 48 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Baseline and Week 18 |
|
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Safety population consited of all patients who received at least one dose of study medication
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fingolimod 0.5mg/Daily | Oral capsule dose was given once daily for 48 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 862-778-8300 |
| ID | Term |
|---|---|
| D009902 | Optic Neuritis |
| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
|
Due to early termination and low patient enrollment this trial was not powered for efficacy
| 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 | 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 | Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 |
| Majadahonda |
| Madrid |
| 28222 |
| Spain |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Secondary | Low Contrast Visual Acuity (LCVA) | Due to early termination and low patient enrollment this trial was not powered for efficacy | Posted | Baseline, Week 48 |
|
|
| Secondary | Vision Based Quality of Life (QoL) Utility Score | Due to early termination and low patient enrollment this trial was not powered for efficacy | Posted | Baseline, Week 18, Week 48 |
|
|
| Secondary | 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 | Posted | Baseline, Week 18, Week 48 |
|
|
| Secondary | 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 | Safety population consited of all patients who received at least one dose of study medication | Posted | Number | Participants | Weeks 0, 4, 8, 12, 18, 24, 36, 48, 60 |
|
|
|
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | 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 | 0 | 0 | 0 | 0 |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| ASTHMA EXACERBATION | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis doesn not prohibit any investigator from publishing. Any publications from a single site are postponed until the publication of the pooled data (i.e. data from all sites) in the clinical trial or disclosure of the trial results in their entirety.
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
| Measurements |
|---|
|