An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.

• Register: EUCTR
• Last refreshed on: 16 October 2012
• Main ID: EUCTR2007-004122-24-CZ
• Date of registration: 03/01/2008
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma AG
• Public title: An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.
• Scientific title: An extension of the 24-month, double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing efficacy and safety of FTY720 1.25 mg and 0.5 mg administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis.
• Date of first enrolment: 30/04/2008
• Target sample size: 1250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004122-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: yes Other trial design description: Dose-blinded until core study results become available, then open label. If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Belgium, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Netherlands, Slovakia, Sweden, United Kingdom

Contacts

• Name: Informacní služba - klin. hodnocení
• Affiliation: Novartis s.r.o.

• Name: Informacní služba - klin. hodnocení
• Affiliation: Novartis s.r.o.

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients should complete the 24 month core study
2. Written informed consent provided prior to participation in extension study
3. Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception

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:
1. Premature discontinuation of the study drug during the core study FTY720D2301 due to:
a. An adverse event or serious adverse event or laboratory abnormality, except pregnancy
b. Conditions leading to permanent study drug discontinuation such as macular edema, elevated liver enzymes five times ULN (upper limit of normal), pulmonary function tests below 60% of baseline values. The full description of these exclusion criteria and monitoring guidelines is outlined in Appendix 4: Guidance on Safety Monitoring
2. Chronic disease of the immune system other than MS which may require immunosuppressive treatment
3. History or presence of malignancy
4. Known diagnosis of diabetes mellitus or a blood glucose obtained suspicious for diabetes (= 126 mg/dl or = 7 mmol/L if fasting; = 200 mg/dl or = 11.1 mmol/L if random)
5. Macular edema during the core study
6. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests
7. Previous treatment with cladribine, cyclophosphamide or mitoxantrone
8. Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months
9. 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
10. Any of the following cardiovascular conditions:
a. myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
b. cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
c. arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide)
d. history or presence of a third degree AV block
e. proven history of sick sinus syndrome or sino-atrial heart block
f. known history of angina pectoris due to coronary spasm or Raynaud’s phenomenon
11. Any of the following pulmonary conditions:
a. Severe respiratory disease or pulmonary fibrosis diagnosed [during the core study]
b. History of tuberculosis
c. Abnormal chest x-ray or high resolution computer tomography (HRCT) [at selected sites] suggestive of active pulmonary disease in the core study
12. Known history of alcohol abuse, chronic liver disease
13. Current participation in any clinical research study evaluating another investigational drug or therapy
14. Female patients that are nursing (lactating)



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

Health Condition(s) or Problem(s) studied

Relapsing-remitting multiple sclerosis.
MedDRA version: 13.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

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

Primary Outcome(s)

Primary end point(s): - Safety:
The safety data from both core and extension studies will be included in the analysis on the safety population. The assessment of safety will be based mainly on the frequency of adverse events and on the incidence of clinically notable laboratory abnormalities. Other safety assessments will include laboratory data summaries, vital signs, bradycardia events, pulmonary function tests, chest x-ray or HRCT, ophthalmic, and ECG data.

- Tolerability:
Tolerability will be assessed by summarizing AEs or abnormal laboratory values by treatment group. No special questionnaires will be offered for assessment of acceptability/tolerability of the study medication.

- Efficacy:
The efficacy variables are annualized relapse rate, time to confirmed disability progression, EDSS score, MSFC score, number of Gd-enhanced T1-weighted lesion, and number of new or newly-enlarged T2 lesions.
No statistical comparisons for the efficacy endpoints will be performed due to the dose changes for patients at their different time points of the study, which makes the statistical comparisons not meaningful.

Please refer to the enclosed Protocol for a detailed description.

Secondary Objective:

Main Objective: Study CFTY720D2301E1 is designed to assess the following properties of FTY720 in patients with relapsing MS:
• To evaluate long-term safety and tolerability
• To evaluate long-term efficacy

Secondary ID(s)

2007-004122-24-SE

CFTY720D2301E1

Source(s) of Monetary Support

Novartis Pharma Services AG