Tolerability and Safety and Health Outcomes in Relapsing Multiple Sclerosis (MS) Patients
- Registration Number
- NCT01127750
- Lead Sponsor
- Novartis
- Brief Summary
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2417
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description FTY720 FTY720 -
- Primary Outcome Measures
Name Time Method Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS 4 months
- Secondary Outcome Measures
Name Time Method Incidence of bradyarrhythmic electrocardiograms (ECGs) 4 months Incidence of macular edema 4 months Patient reported outcomes indices in multiple sclerosis (PRIMUS), short form health survey-12, and treatment satisfaction questionnaire for medication (TSQM-9) 4 months
Trial Locations
- Locations (6)
Neuroscience Research of the Berkshires
🇩🇪Krefeld, Germany
Novartis Investigational Site
🇬🇧Truro, United Kingdom
Novarris Investigative Site
🇩🇪Berlin, Germany
Novartis Investigative Site
🇮🇹Viterbo, Italy
Novartis Investigative SIte
🇮🇹Asti, Italy
Novaratis Investigative Site
🇩🇪Bochum, Germany