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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 28 September 2015
Main ID:  EUCTR2012-000835-18-PL
Date of registration: 06/06/2014
Prospective Registration: Yes
Primary sponsor: Novartis Pharma Services AG
Public title: A study to evaluate how safe and effective 0.5 mg FTY720 is in delaying disability progression if taken once daily, in patients with PPMS
Scientific title: Open-label, single-arm extension study to the double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg FTY720 administered orally once daily versus placebo in patients with primary progressive multiple sclerosis - efficacy and safety of 0.5 mg fingolimod in patients with primary progressive multiple sclerosis
Date of first enrolment: 22/07/2014
Target sample size: 700
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000835-18
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: no Placebo: no Other: no Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Australia Belgium Canada Czech Republic Denmark Finland France Germany
Hungary Italy Netherlands Poland Spain Sweden Switzerland Turkey
United Kingdom United States
Contacts
Name: Clinical Trial Information Desk   
Address:  Lichtstrasse 35 4056 Basel Switzerland
Telephone: +4161324 1111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma Services AG
Name: Clinical Trial Information Desk   
Address:  Lichtstrasse 35 4056 Basel Switzerland
Telephone: +4161324 1111
Email: clinicaltrial.enquiries@novartis.com
Affiliation:  Novartis Pharma Services AG
Key inclusion & exclusion criteria
Inclusion criteria:
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
Patients who have provided written informed consent
Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, who have completed at least 3 years on study drug treatment at the time of extension study initiation
Patients initially randomized to fingolimod 0.5 mg or placebo as part of the second study cohort who have continued on study drug treatment until such time as the last ongoing patient enrolled in the study has reached 3 years in study.
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 700
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren’s syndrome, Crohn’s disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).
2. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, hepatitis A, hepatitis B, hepatitis C, hepatitis E infection or to have positive HIV antibody, hepatitis B surface antigen or hepatitis C antibody tests.
3. Uncontrolled diabetes mellitus (HbA1c>7%).
4. Not applicable – this exclusion criterion was deleted in Amendment 1.
5. Macular edema at baseline.
6. Treatment with Class Ia or III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide).
7. Any of the following cardiovascular conditions:
• myocardial infarction within the past 6 months prior to enrollment or current unstable ischemic heart disease
• cardiac failure at time of Screening (Class III, according to NYHA Classification; Appendix 2) or any severe cardiac disease as determined by the investigator
• second degree AV block Mobitz type II or a third degree AV block on screening ECG
• an increased QTc (Fridericia and Bazett) interval >500 ms on Screening ECG
• hypertension, uncontrolled by medication
8. Any of the following pulmonary conditions:
• severe respiratory disease or pulmonary fibrosis
• active tuberculosis
9. Any of the following hepatic conditions at Baseline:
• severe hepatic injury (Child-Pugh class C)
• history of alcohol abuse, chronic liver or biliary disease, acute or chronic pancreatitis, with the exception of Gilbert’s syndrome
• total or conjugated bilirubin greater than the upper limit of the normal range, unless in context of Gilbert’s syndrome
• two consecutive alkaline phosphatase (AP) values greater than 3 times the upper limit of the normal range
• two consecutive AST (SGOT), ALT (SGPT) values greater than 3 times the upper limit of the normal range
• two consecutive gamma-glutamyl-transferase (GGT) values greater than 3 times the upper limit of the normal range
10. Any medically unstable condition, as assessed by the primary treating physician.
11. Participation in any clinical research study other than CFTY720D2306 evaluating another investigational drug or therapy within 6 months prior to extension baseline.
12. 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).
13. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using highly effective contraception during dosing with study treatment. Highly effective contraception includes:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Male partner sterilization (at


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary progressive multiple sclerosis.
MedDRA version: 18.0 Level: PT Classification code 10063401 Term: Primary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

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

Primary Outcome(s)
Main Objective: To assess the long-term safety, tolerability, and efficacy (as measured by clinical and MRI parameters of disease activity) of fingolimod 0.5 mg/day in PPMS patients.
Primary end point(s): long-term safety, tolerability, and efficacy
Secondary Objective: none
Timepoint(s) of evaluation of this end point: Physical examination: baseline, yearly
Vital signs: every visit
Laboratory evaluations: every visit
Electrocardiogram (ECG): baseline, day 1
Dermatological examination: baseline, yearly
Ophthalmic examination: baseline, month 3
EDSS, 9HPT, 25TWT: baseline, every 6 months
MRI: baseline, yearly
Pregnancy test: every visit
Secondary Outcome(s)
Secondary end point(s): none
Timepoint(s) of evaluation of this end point: none
Secondary ID(s)
2012-000835-18-SE
CFTY720D2306E1
Source(s) of Monetary Support
Novartis Pharma Services AG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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