Status:
TERMINATED
This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Primary Progressive Multiple Sclerosis
Eligibility:
All Genders
25-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate whether FTY720 is effective in delaying MS disability progression compared to placebo in patients with PPMS. This was an open-label, single-arm extension study...
Eligibility Criteria
Inclusion
- General
- sign written informed consent prior to participating in the study
- 25 through 65 years of age inclusive
- females of childbearing potential must:
- have a negative pregnancy test at Baseline (prior to randomization) and
- use simultaneously two forms of effective contraception during the treatment and 3-months after discontinuation of study medication
- Primary Progressive Multiple sclerosis.
- diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
- time since first reported symptoms between 2 and 10 years
- evidence of clinical disability progression in the 2 years prior to Screening
- disability status at Screening
- EDSS score of 3.5-6.0 inclusive
- pyramidal functional system score of 2 or more
- 25'TWT less than 30 seconds
- Extension study Inclusion criteria
- Patients initially randomized to fingolimod 1.25 mg or placebo as part of the first study cohort, were to 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, were to have continued on study drug treatment until such time as the last ongoing patient enrolled in the study had reached 3 years in study
Exclusion
- PPMS specific:
- History of relapses/attacks
- Progressive neurological disorder other than PPMS
- Pure cerebellar syndrome or pure visual progressive syndrome or pure
- cognitive progressive syndrome
- Presence of spinal cord compression at screening MRI
- Relevant history of vitamin B12 deficit
- Evidence of syphilis or borreliosis at Screening
- Cardiovascular conditions:
- Myocardial infarction within the past 6 months or current unstable ischemic heart disease
- History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
- Severe cardiac failure or cardiac arrest
- History of symptomatic bradycardia
- Resting pulse \<55 bpm pre-dose
- History of sick sinus syndrome or sino-atrial heart block
- History or presence of second and third degree AV block or an increase QT interval (QTc\>440 ms)
- Arrythmia requiring treatment with class III antiarrythmic drugs
- History of positive tilt test from workout of vasovagal syncope
- Hypertension, not controlled with medication
- Pulmonary:
- Severe respiratory disease or pulmonary fibrosis
- TB
- Abnormal X-ray, suggestive of active pulmonary disease
- Abnormal PFT: \<70% of predicted for FEV1 and FVC; \<60% for DLCO
- Patients receiving chronic (daily) therapies for asthma
- Hepatic:
- Known history of alcohol abuse, chronic liver or biliary disease
- Total or conjugated Brb \>ULN, unless in context of Gilbert's syndrome
- AP \>1.5xULN; ALT/AST \>2xULN; GGT\>3xULN
- Other:
- History of chronic disease of the immune system other than MS
- Malignancy (other than successfully treated SCC or BCC)
- Diabetes Mellitus
- Macular Edema present at screening
- HIV, Hepatitis C or B, other active infection
- History of total lymphoid irradiation or bone marrow transplantation
- Serum creatinine \>1.7 mg/dl
- WBC \<3500 cells/mm3
- Lymphocyte count \<800 cells/mm3
- History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
- Unable to undergo MRI scans
- Participation in any therapeutical clinical research study in the 6 months prior to randomization
- Pregnant or lactating women
- Drugs requiring wash-out period:
- 3 months:
- Systemic corticosteroids or ACTH
- INF-beta
- 6 months:
- Immunosuppressive medication
- Immunoglobulins
- Monoclonal antibodies
- Drugs that exclude participation in the study:
- Cladribine
- Cyclophosphamide
- Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)
- Extension study Exclusion criteria
- Patients were not eligible for enrollment in the extension study if they had any of the following key exclusion criteria at the extension study Baseline visit: active chronic immune system disease other than MS (or stable disease treated with immune therapy); known immunodeficiency syndrome; active infection; uncontrolled diabetes mellitus; macularedema; treatment with Class Ia or III antiarrhythmic drugs; any of the specified cardiac, pulmonary, or hepatic conditions; or any medically unstable condition
Key Trial Info
Start Date :
July 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2015
Estimated Enrollment :
970 Patients enrolled
Trial Details
Trial ID
NCT00731692
Start Date
July 28 2008
End Date
June 22 2015
Last Update
June 14 2017
Active Locations (157)
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1
Novartis Investigative Site
Newport Beach, California, United States, 92660
2
Novartis Investigative Site
Sacramento, California, United States, 95817
3
Novartis Investigative Site
Aurora, Colorado, United States, 80045
4
Novartis Investigative Site
Pompano Beach, Florida, United States, 33060