Tolerability and Safety and Health Outcomes in Relapsing Multiple Scle
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
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
What it measured
Main measures
Evaluate the safety and tolerability profile of FTY720 in patients with relapsing forms of MS
4 months
SafetyAdverse events (AEs), laboratory, vital signs, 1st dose Holter-ECG-recording, and ophthalmology assessments and skin assessment data will be used to evaluate the primary objective.
Safety
Other measures (3)
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)
4 months
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 65
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will assess tolerability and safety and health outcomes in relapsing MS patients taking FTY720.
Papers
Loading reviews and guidelines…
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History
Started
May 2010
Main results due
Oct 2011
Finished
Oct 2011