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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019029-32 | EudraCT Number |
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This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FTY720 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FTY720 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of macular edema | 4 months | |
| Incidence of bradyarrhythmic electrocardiograms (ECGs) | 4 months | |
| Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Box Hill | 3128 | Australia | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24221641 | Result | Gold R, Comi G, Palace J, Siever A, Gottschalk R, Bijarnia M, von Rosenstiel P, Tomic D, Kappos L; FIRST Study Investigators. Assessment of cardiac safety during fingolimod treatment initiation in a real-world relapsing multiple sclerosis population: a phase 3b, open-label study. J Neurol. 2014 Feb;261(2):267-76. doi: 10.1007/s00415-013-7115-8. Epub 2013 Nov 13. |
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| 4 months |
| Heidelberg |
| 3084 |
| Australia |
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| Novartis Investigative Site | Liverpool | 2170 | Australia |
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| Novartis Investigational Site | Vienna | 1090 | Austria |
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| Novartis Investigational Site | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
Not provided
Not provided