acute demyelinating optic neuritis MedDRA version: 14.1 Level: PT Classification code 10030942 Term: Optic neuritis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: GILENYA 0,5 mg capsulas duras
Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359- 56-0
Current Sponsor cod
Sponsors
Novartis Farmaceutica, S.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Written informed consent must be obtained before any assessment is performed. ? Male and female patients aged between 18 and 50 years, inclusive. ? Clinical signs and symptoms of unilateral ADON (loss of vision, pain on movement, impairment of color vision) starting within the 14 days prior to intended randomization. ? The qualifying ADON must be the first clinical episode of a probable demyelinating disease. ? Able to undergo treatment with intravenous methylprednisolone (IVMP). ? Received first IVMP dose prior to Visit 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 126 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? History of any unexplained eye or neurological symptomatology lasting longer than 48 hours and indicative of a demyelinating disorder. ? Bilateral optic neuritis. ? Functionally or clinically relevant comorbidity of either eye such as glaucoma, optic nerve hypoplasia, macular full or partial thickness macular hole, macular edema, vitreomacular traction, epiretinal membrane, uveitis, or other diseases of the optic nerve or a history thereof. ? High clinical likelihood of a form of optic neuritis other than ADON (e.g., severe optic disk edema, atrophic optic disk, retinal exudates, or hemorrhages). ? Total average RNFL thickness of less than or equal to 80 ?m in the fellow eye (unaffected eye) ? Patients meeting any of the following cardiovascular conditions at Screening: a. history of cardiac arrest; b. severe untreated sleep apnea; c. history of myocardial infarction; congestive heart failure; d. ischemic heart disease; e. cerebrovascular disease; f. patients receiving current treatment with Class Ia or III antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline, procainamide). g. patients with relevant risk factors for QT prolongation, for example, hypokalaemia, hypomagnesemia or congenital QT prolongation; h. history or presence of a second-degree AV block Type II or third-degree AV block or corrected QTc inverval >450 msec in males and >470 msec in females corrected using Fridericia?s formula (based on screening ECG report from central reader); i. history of sick sinus syndrome or sino-atrial heart block; j. uncontrolled hypertension despite prescribed medications; k. resting heart rate <45 bpm; ? Patients receiving current treatment (at randomization) beta blockers, heart-rate slowing calcium channel blockers (e.g. ivadrabine, verapamil, or diltiazem), or other substances which may decrease heart rate such as digoxin, anticholinesteratic agents or pilocarpine. Advice from a cardiologist should be sought regarding the switch to non-heart-rate lowering medicinal products (for more details, please refer to Appendix 3) ? Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test. ? Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during the study and for 2 months after stopping treatment. ? Highly effective contraception ? is defined as contraception that results in less than 1% unwanted pregnancies when used properly according to the label.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if fingolimod will reduce the mean retinal nerve fiber layer (RNFL) thinning (measured as the OCT-determined difference between the RNFLT of the affected eye after 18 weeks of treatment and the baseline RNFLT of the fellow eye) relative to placebo in patients with suspected ADON, all of whom will receive standard steroid treatment.;Secondary Objective: ? To compare the impact of immediate treatment with fingolimod 0.5 mg/daily (48 weeks of continuous treatment) versus delayed treatment with fingolimod 0.5 mg/daily (18 weeks of placebo then 30 weeks of fingolimod) in patients with suspected ADON who are receiving standard treatment with steroids on the following outcomes: ? Low-contrast visual acuity of the affected eye assessed by low-contrast Sloan letter charts at 1.25 and 2.5% contrast levels at 48 weeks. ? Vision-based quality of life (QoL) as assessed by the QoL questionnaire NEI-VFQ-25 at weeks 18 and 48. ? The proportion of patients converting to 2010 McDonald MS (Polman et al. 2011) between the assessment at the screening visit and weeks 18 and 48. ? To evaluate the tolerability and safety of fingolimod in patients with ADON;Primary end point(s): RNFL thinning, to evaluate whether immediate treatment with fingolimod can reduce the axonal loss of retinal neurons following an episode of ADON;Timepoint(s) of evaluation of this end point: after 18 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): assessment of whether immediate treatment with fingolimod can reduce the loss of visual acuity following an episode of ADON;Timepoint(s) of evaluation of this end point: when full stabilization of the visual function | — |
Countries
Canada, Germany, Italy, Portugal, Spain, United Kingdom, United States
Contacts
Public ContactDepartamento Médico (ICRO)
Novartis Farmaceutica, S.A.
Outcome results
None listed