Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01127750
First received: May 19, 2010
Last updated: January 18, 2012
Last verified: January 2012
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Purpose
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsing Multiple Sclerosis |
Drug: FTY720 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 4-month, Open-label, Multi-center Study to Explore Tolerability and Safety and Health Outcomes of FTY720 in Patients With Relapsing Forms of Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of macular edema [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Incidence of bradyarrhythmic electrocardiograms (ECGs) [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
- Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 2417 |
| Study Start Date: | May 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FTY720 | Drug: FTY720 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18-65 years of age, must have relapsing MS
Exclusion Criteria:
- Patients with a type of MS that is not relapsing
- Patients with history of chronic immune disease
- Patients with a history of certain cancers
- Diabetic patients with certain eye disorders
- Patients who are on certain immunosuppressive medications or heart medications
- Patients with certain heart conditions
- Patients with certain lung conditions
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127750
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| Australia | |
| Novartis Investigative Site | |
| Box Hill, Australia, 3128 | |
| Novartis Investigative Site | |
| Heidelberg, Australia, 3084 | |
| Novartis Investigative Site | |
| Kogarah, Australia, 2217 | |
| Novartis Investigative Site | |
| Liverpool, Australia, 2170 | |
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| Woodville South, Australia, 5011 | |
| Austria | |
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| Linz, Austria, A-4020 | |
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| Vienna, Austria, 1090 | |
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| Vienna, Austria, 1010 | |
| Belgium | |
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| Brugge, Belgium, 8000 | |
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| Bruxelles, Belgium, 1200 | |
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| Bruxelles, Belgium, 1070 | |
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Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01127750 History of Changes |
| Other Study ID Numbers: | CFTY720D2316, 2010-019029-32 |
| Study First Received: | May 19, 2010 |
| Last Updated: | January 18, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Novartis:
|
Relapsing multiple sclerosis MS safety tolerability health outcomes |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Pathologic Processes Fingolimod Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013