A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND

• Register: EUCTR
• Last refreshed on: 2 October 2012
• Main ID: EUCTR2010-019029-32-IT
• Date of registration: 09/04/2010
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• Public title: A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND
• Scientific title: A 4-month, open-label, multi-center study to explore tolerability and safety and health outcomes of FTY720 in patients with relapsing forms of multiple sclerosis - ND
• Date of first enrolment: 27/04/2010
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-019029-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Austria, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Portugal, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

Inclusion 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. Male or female subjects aged 18-65 years 3. Subjects with relapsing forms of MS (RRMS, SPMS with superimposed relapses), defined by 2005 revised McDonald criteria
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study: 1. Patients with a manifestation of MS other than relapsing MS. 2. Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome. 3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. 4. Patients with uncontrolled diabetes mellitus (HbA1c > 7%). 5. Diagnosis of macular edema during Screening Phase (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the ophthalmic screening visit). 6. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests. 7. Negative for varicella-zoster virus IgG antibodies at Screening 8. Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline 9. Patients who have received total lymphoid irradiation or bone marrow transplantation. 10. Patients who expect to be treated with any disease modifying drugs (DMD) during the study (i.e. IFN-ß, glatiramer acetate); however no washout is needed for DMDs prior to baseline. 11. Patients who have been treated with: ? corticosteroids or adrenocorticotropic hormones (ACTH) within 1 month prior to randomization; ? immunosuppressive medications such as azathioprine or methotrexate within 3 months prior to baseline; ? immunoglobulins and/or monoclonal antibodies (including natalizumab) within 3 months prior to baseline; ? cladribine, cyclophosphamide or mitoxantrone at any time. 12. Patients with any medically unstable condition, as assessed by the primary treating physician at each site. 13. Patients with any of the following cardiovascular conditions and/or findings in the screening ambulatory 24-hour ECG-recording: ? history of cardiac arrest; ? myocardial infarction within the past 6 months prior to enrollment or with current unstable ischemic heart disease; ? known history of angina pectoris due to coronary spasm or history of Raynaud?s phenomenon; ? cardiac failure at time of Screening (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; ? history or presence of a Mobitz 2 second degree AV block or a third degree AV block or an increased QTc interval >450 ms in males and >470 ms in females corrected using Bazett?s formula; ? Patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) and III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide). ? resting pulse rate <45 bpm prior to baseline; ? bradycardia measured by continuous ambulatory ECG of <40 bpm at any hour (mean) or of <30 bpm at any time (beat to beat) ? proven history of sick sinus syndrome or sino-atrial heart block; ? hypertension, not controlled by prescribed medications 14. Patients with any of the following pulmonary conditions: ? pulmonary fibrosis; ? active tuberculosis; 15. Patients with any of the following hepatic conditions ? chronic liver or biliary disease; ? total bilir

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

Health Condition(s) or Problem(s) studied

MS (MULTIPLE SCLEROSIS)
MedDRA version: 12.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis

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: FTY720
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-

Primary Outcome(s)

Primary end point(s): Adverse events (AEs), laboratory, vital signs, 1st dose Holter-ECG-recording, and ophthalmology assessments and skin assessment data will be used to evaluate the primary objective. Please see Section 8 of the enclosed protocol for a detailed description.

Secondary Objective: N/A

Main Objective: To evaluate the safety and tolerability profile of FTY720 0.5 mg in patients with relapsing forms of MS including a broader patient population than has been previously studied in clinical trials with FTY720.

Secondary ID(s)

CFTY720D2316

2010-019029-32-DE