OL, 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
Status: | Completed |
---|---|
Conditions: | Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 28 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2013 |
End Date: | June 2015 |
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
To provide data on the long-term safety and tolerability of FTY720 in patients with primary
progressive MS when administered via capsule once daily.
progressive MS when administered via capsule once daily.
Inclusion Criteria: (1) Patients who have provided written informed consent (2a) 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 OR (2b) 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.
Exclusion Criteria:
- Active chronic disease of the immune system other than MS or a known immunodeficiency
syndrome,
- Active systemic bacterial, viral or fungal infections,
- Uncontrolled diabetes mellitus,
- Positive lab markers for hepatitis A, B, C, and E indicating acute or chronic
infection, * Macular edema at baseline
- Treatment with Class Ia or III antiarrhythmic drugs, cardio-vascular conditions
including Myocardial infarction, current unstable ischemic heart disease, cardiac
failure or any severe cardiac disease, increased QTc (Fridericia and Bazett) interval
>500 ms, Hypertension, uncontrolled by medication; Pulmonary conditions including
severe respiratory disease or pulmonary fibrosis, active tuberculosis; Hepatic
conditions including elevated Total or conjugated bilirubin, elevated consecutive
alkaline phosphatase, AST (SGOT), ALT (SGPT) or gamma-glutamyl-transferase values
greater; Any medically unstable condition, or participation in any clinical research
study other than CFTY720D2306; pregnant or nursing (lactating) women - Other
protocol-defined inclusion/exclusion criteria may apply
We found this trial at
19
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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