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.

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Primary Progressive Multiple Sclerosis

In brief

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 to a double-blind, randomized multicenter, placebo-controlled, parallel-group core study. The core study completed and eligible patients enrolled into the extension study at the next scheduled or unscheduled core study visit. All patients, regardless of their treatment in the core study, received fingolimod 0.5 mg in the extension study. The extension study was terminated early after the results of the core study became available showing that the study did not meet its primary endpoint which was defined as confirmed disability progression in this population

Key facts

Study ID

NCT00731692

Run by

Novartis Pharmaceuticals

People needed

970

Starts

2008-07-28

Expected to finish

2015-06-22

Last updated by the study team

2017-06-14

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Aurora, Colorado, United States
• Novartis Investigative Site — Pompano Beach, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Atlanta, Georgia, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Kansas City, Kansas, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Brookline, Massachusetts, United States
• Novartis Investigative Site — Detroit, Michigan, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Teaneck, New Jersey, United States
• Novartis Investigative Site — Buffalo, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Stony Brook, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Durham, North Carolina, United States
• Novartis Investigative Site — Cleveland, Ohio, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — Knoxville, Tennessee, United States
• Novartis Investigative Site — Newport Beach, California, United States

Full record on ClinicalTrials.gov

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