Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis

• Register: EUCTR
• Last refreshed on: 12 November 2018
• Main ID: EUCTR2010-020515-37-BE
• Date of registration: 28/10/2010
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Long-term safety, tolerability and efficacy study of 0.5 mg fingolimod once daily in patients with multiple sclerosis
• Scientific title: A single arm, open-label, multicenter study evaluating the long-term safety, tolerability and efficacy of 0.5 mg fingolimod (FTY720) administered orally once daily in patients with multiple sclerosis.
• Date of first enrolment: 17/12/2010
• Target sample size: 5000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020515-37
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Costa Rica, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Jordan, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Panama, Peru, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Venezuela, Bolivarian Republic of

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma AG

Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Patients who have completed designated ongoing or planned trials with fingolimod, including phase II/III patients who have already completed CFTY720D2399, CFTY720D2309/E1 or one of the phase II/III core or extension studies.
3. Patients who participated in any designated global fingolimod MS trial other than phase II/III (e.g. CFTY720D2316, CFTY720D2320, etc.) and are less than 180 days beyond the time of local approval and general reimbursement.
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 4000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1000

Exclusion criteria:
Patients fulfilling any of the following criteria are not eligible for
inclusion in this study:
1. Premature permanent discontinuation from any fingolimod study due
to:
a. An adverse event or serious adverse event or laboratory abnormality.
b. Conditions leading to permanent study drug discontinuation.
Patients who temporarily or permanently discontinued from any
fingolimod study because of pregnancy can be re-enrolled.
2. 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 (> 5 mIU/ml).
3. 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'defined as
contraception which results in less that 1% unwanted pregnancies when
used properly according to the label.
Women are considered post-menopausal and not of child-bearing
potential if they have had 12 months of natural (spontaneous)
amenorrhea with an appropriate clinical profile (e.g. age appropriate,
history of vasomotor symptoms) or have had surgical bilateral
oophorectomy (with or without hysterectomy) or tubal ligation at least
six weeks prior to baseline. In the case of oophorectomy alone, only
when the reproductive status of the woman has been confirmed by
follow up hormone level assessment is she considered not of child
bearing potential.
4. Chronic disease of the immune system other than MS which may
require immunosuppressive treatment.
5. Severe active infection or active chronic infection.
6. Previous treatment with cladribine, cyclophosphamide or
mitoxantrone.
7. Treatment with monoclonal antibodies (including Natalizumab) in the
past 3 months.
8. Uncontrolled diabetes (HbA1c>9%).
9. Macular edema at Baseline.
10. Any medically unstable condition that may interfere with the
patient's ability to cooperate and comply with the study procedures, as
assessed by the treating physician.
11. Any of the following cardiovascular conditions:
a. myocardial infarction within the past 6 months prior to enrollment or
current unstable ischemic heart disease;
b. cardiac failure at time of Screening (Class III & IV, according to New
York Heart Association Classification) or any severe cardiac disease as
determined by the investigator;
c. patients receiving current treatment with Class Ia and III
antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone,
bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline,
procainamide);
d. second-degree AV block Type II or third-degree AV block or corrected
QTc inverval >500 msec;
e. sick sinus syndrome or sino-atrial heart block;
f. uncontrolled hypertension despite prescribed medications.
12. Any of the following pulmonary conditions during the previous
fingolimod study or observed at enrollment visit:
a. severe respiratory disease or pulmonary fibrosis;
b. active tuberculosis;
c. in patients enrolling from studies with regular spirometry: reduction of
FEV1, FVC and/or DLCO below 60% of core study baseline values or if
FEV1, FVC and/or DLCO at extension study baseline is the second of two
consecutive pulmonary function tests with values <80% of core study
baseline.
13. Severe liver impairment or chronic liver disease.
14. Positive screening for serologica

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing multiple sclerosis
MedDRA version: 14.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: Fingolimod
Product Code: FTY720D
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Fingolimod
CAS Number: 162359-56-0
Current Sponsor code: FTY720D
Other descriptive name: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Primary Outcome(s)

Main Objective: This study is designed to evaluate the long-term safety and tolerability of fingolimod 0.5 mg/day in patients with relapsing forms of MS.

Primary end point(s): Long-term safety will be assessed based on adverse events (AEs), laboratory and vital signs as well as other investigations performed when clinically indicated.

Secondary Objective: This study will also evaluate long-term efficacy of fingolimod 0.5 mg/day
in patients with MS, as measured by disability progression, brain volume
(atrophy), T1- (non-enhanced) and T2-weighted lesion volume and MS
relapse occurrence

Timepoint(s) of evaluation of this end point: Visits every 3 months through Month 12 (v5); Visits every 6 months
beginning after Month 12 at Month 18 (v6)

Secondary Outcome(s)

Secondary end point(s): MRI, MS relapse, EDSS scores, MSFC scores

Timepoint(s) of evaluation of this end point: Visits every 3 months through Month 12 (v5); Visits every 6 months beginning after Month 12 at Month 18 (v6)

Secondary ID(s)

2010-020515-37-FI

CFTY720D2399

Source(s) of Monetary Support

Novartis Pharma AG