Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)
This study is not yet open for participant recruitment.
Verified January 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01757691
First received: December 21, 2012
Last updated: January 10, 2013
Last verified: January 2013
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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.
| Estimated Enrollment: | 126 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757691
Contacts
| Contact: Novartis Pharmaceuticals | +1(862)778-8300 |
Locations
| United States, Colorado | |
| Novartis Investigative Site | Not yet recruiting |
| Aurora, Colorado, United States, 80045 | |
| United States, Connecticut | |
| Novartis Investigative Site | Not yet recruiting |
| Danbury, Connecticut, United States, 06810 | |
| Novartis Investigative Site | Not yet recruiting |
| Fairfield, Connecticut, United States, 06824 | |
| United States, Florida | |
| Novartis Investigative Site | Not yet recruiting |
| St. Petersburg, Florida, United States, 33713 | |
| Novartis Investigative Site | Not yet recruiting |
| Sunrise, Florida, United States, 33351 | |
| United States, Georgia | |
| Novartis Investigative Site | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, North Carolina | |
| Novartis Investigative Site | Not yet recruiting |
| Durham, North Carolina, United States, 27710 | |
| United States, Oklahoma | |
| Novartis Investigative Site | Not yet recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Washington | |
| Novartis Investigative Site | Not yet recruiting |
| Seattle, Washington, United States, 98122 | |
| Italy | |
| Novartis Investigative Site | Not yet recruiting |
| Milano, MI, Italy, 20132 | |
| Novartis Investigative Site | Not yet recruiting |
| Milano, MI, Italy, 20122 | |
| Novartis Investigative Site | Not yet recruiting |
| Roma, RM, Italy, 00133 | |
| Novartis Investigative Site | Not yet recruiting |
| Savona, SV, Italy, 17100 | |
| Portugal | |
| Novartis Investigative Site | Not yet recruiting |
| Amadora, Portugal, 2720-276 | |
| Novartis Investigative Site | Not yet recruiting |
| Coimbra, Portugal, 3000-075 | |
| Novartis Investigative Site | Not yet recruiting |
| Porto, Portugal, 4099-001 | |
| Spain | |
| Novartis Investigative Site | Not yet recruiting |
| Sant Cugat, Barcelona, Spain, 08190 | |
| Novartis Investigative Site | Not yet recruiting |
| Hospitalet de Llobregat, Cataluña, Spain, 08907 | |
| Novartis Investigative Site | Not yet recruiting |
| Valencia, Comunidad Valenciana, Spain, 46010 | |
| Novartis Investigative Site | Not yet recruiting |
| Santiago de Compostela, Galicia, Spain, 15706 | |
| Novartis Investigative Site | Not yet recruiting |
| Majadanonda, Madrid, Spain, 28220 | |
| Novartis Investigative Site | Not yet recruiting |
| San Sebastian, Pais Vasco, Spain, 20014 | |
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: | January 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Acute demyelinating optic neuritis Optic neuritis |
Additional relevant MeSH terms:
|
Neuritis Optic 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 May 16, 2013