Status:
COMPLETED
Disease Control in RRMS Transferring Treatment From Natalizumab to Fingolimod
Lead Sponsor:
University Hospital, Basel, Switzerland
Collaborating Sponsors:
Novartis
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
This is an observational study to develop new hypothesis regarding the dynamic and safety of switching from natalizumab to fingolimod: * Comparison of disease activity (clinical and MRI) during the y...
Detailed Description
The risk of progressive multifocal leukoencephalopathy (PML) upon treatment with natalizumab increases over time, at least into the 3rd year of therapy. Many Multiple Sclerosis (MS) patients who are c...
Eligibility Criteria
Inclusion
- Male and female subjects aged 18-65 years
- Subjects with RRMS, defined by 2010 revised McDonald criteria
- Patients with Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive
- Patients on treatment with natalizumab for at least 6 months prior to screening
Exclusion
- Patients with serious cardiovascular conditions and/or history or presence of a second- and third-degree aortic valve (AV) block, corrected QT interval (QTc) \>450 ms in males and \>470 ms in females
- Patients receiving class Ia or III antiarrhythmic drugs
- Patients with proven history of sick sinus Syndrome (SSS) or sinoatrial (SA) heart block
- Patients with uncontrolled hypertension
- Patients with resting heart rate (HR) \<45 bpm
- Patients who have been treated with Fingolimod or cladribine at any time
- Patients with a history of malignancy of any organ system
- Patients with severe respiratory or hepatic disease
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02277964
Start Date
March 1 2012
End Date
August 1 2016
Last Update
September 14 2016
Active Locations (1)
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1
University Hospital Basel, Switzerland
Basel, Switzerland, 4031