A study to evaluate the effects of fingolimod teatment in patients with acute demyelinating optic neuritis

• Conditions: acute demyelinating optic neuritis; MedDRA version: 15.1Level: PTClassification code 10030942Term: Optic neuritisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-002968-27-IT
• Lead Sponsor: ovartis Farma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-07
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 126

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

• 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 µm 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified