ENGYNE
What it found
The trial ended early for another reason (see below).
What was tested
Treatment tested
What it measured
Main measures
Number of patients with active MRI lesions
12 months
MRI lesionsBladder, bowel and sexual functionImmune response
Other measures (1)
Number of patients with adverse events
12 months
Safety
Who could take part
Relapsing MS · 18 to 65
Inclusion Criteria: * Male or female subjects aged 18-65 years * Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria * Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5 * Interferon-beta (IFN-β) treatment for at least 18 months. * Positive IFN-NAb titer at screening or within 6 months prior to screening * Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months) Exclusion Criteria: * patients with previous or current disease of immune system * active infections * cardiovascular risk patients * Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA 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
Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months
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History
Started
Jun 2013
Main results due
Jun 2014
Finished
Jun 2014
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