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

Phase 1

• Conditions: Relapsing multiple sclerosis; MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-020515-37-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-12
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 5000

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 Novartis global clinical trials with fingolimod and are unable to obtain fingolimod outside a clinical trial.
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 5000
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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, except pregnancy.
b. Conditions leading to permanent study drug discontinuation. Patients who temporarily or permanently discontinued from any fingolimod study 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). Patients who temporarily or permanently discontinued from any fingolimod study because of pregnancy can be re-enrolled.
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 than 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, yclophosphamide 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 that have developed during the previous fingolimod study or observed at the enrollment visit:
a. myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease;
b. cardiac failure at 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 or III antiarrhythmic drugs (e.g., quinidine, disopyramide, amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide, ajmaline, procainamide);
d. 2nd degree AV block Type II or 3rd degree AV block or corrected QTc interval >450 msec in males or 470 msec in females.
e. sick sinus syndrome or sino-atrial heart block;
f. uncontrolled hypertension;
12. Any of the following pulmonary conditions during the previous fingolimod study or observed at the 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 co

Study & Design

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