Clareo Health | 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.
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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
25–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
General
1. sign written informed consent prior to participating in the study
2. 25 through 65 years of age inclusive
3. 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.
1. diagnosis of primary progressive multiple sclerosis (according to the 2005 Revised McDonald criteria):
2. time since first reported symptoms between 2 and 10 years
3. evidence of clinical disability progression in the 2 years prior to Screening
4. 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
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 be 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
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)
