To investigate if treatment with Imatinib results in a better outcome than standard care in form of Methylprednisolone(MP) after MS-associated relapses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Tablets 400 mg
1 g tablets or infusion
Rigshospitalet
Copenhagen, Denmark
NOT_YET_RECRUITINGUniklinik Köln
Cologne, Germany
RECRUITINGFunctional system score (FSS) change in the most worsened FSS after 28 days due to the acute relapse
The primary endpoint is mean change between baseline and day 28 in the most worsened FSS due to the acute relapse comparing MP and Imatinib. In case more than one domain is affected, priority of selected FSS should be in the following order: 1) Pyramidal, 2) Brain stem, 3) Cerebellar, 4) Visual, 5) Sensory. At least a two step deterioration due to neuroinflammatory bout should have occurred. Bowel and Cerebral domains will not be considered in the primary endpoints. The FSS is graded accordingly: 1. Visual function. Grade 0-6 2. Brain stem function grade 0-5 3. Pyramidal function, grade 0-6 4. Cerebellar function, grade 0-5 5. Sensory function grade 0-6 6. bowel/bladder function 7. Cerebral functions
Time frame: 28 days
Functional system score (FSS) change between baseline and week 12 in the most worsened FSS due to the acute relapse
In case more than one domain is affected, priority of selected FSS should be in the following order: 1) Pyramidal, 2) Brain stem, 3) Cerebellar, 4) Visual, 5) Sensory. At least a two step deterioration due to neuroinflammatory bout should have occurred.
Time frame: 12 weeks
Mean expanded disability status scale (EDSS) change between baseline and day 28
Calculation of EDSS summary score is based on the FSS score, from 0-5 with 0 representing normal neurological exam and 10 representing death by MS
Time frame: 28 days
Mean change in 9-hole peg test (evaluates upper limb function) between baseline and day 28
Evaluates upper limb function
Time frame: 28 days
Mean change in timed 25- walk between baseline and day 28
Time frame: 28 days
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Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGUKSH Campus Kiel
Kiel, Germany
RECRUITINGHaukeland sjukhus
Bergen, Norway
NOT_YET_RECRUITINGAkershus University Hospital
Lørenskog, Norway
NOT_YET_RECRUITINGRikshospitalet, Oslo
Oslo, Norway
NOT_YET_RECRUITINGUllevåls sjukhus
Oslo, Norway
NOT_YET_RECRUITINGKarolinska Universityhospital, Huddinge
Huddinge, Stockholm County, Sweden
RECRUITINGNeurology Sahlgrenska Hospital
Gothenburg, Sweden
RECRUITING...and 4 more locations
Mean change in symbol digital modality test (SDMT) between baseline and day 28
Evaluates cognitive function, with a score range of 0 to 110, with 110 representing the best cognitive function
Time frame: 28 days
Mean change in Multiple Sclerosis Impact Scale (MSIS-29; MS-specific quality of life (QoL) scale) between baseline and day 28
The MISIS-29 consists of 29 items (composed of 20- item physical scale and a 9-item psychological scale), graded from 1-5 points with 5 indicating the most severe impact. The points for the two scales are individually summarized. The physical scale results in a sum with a range 20-100 , where 100 indicates the worse health. The psychological scale is similarly resulting in a range between to 9- 45, where 9 is the least and 45 is the worst.
Time frame: 28 days
Mean change in EQ5D (EuroQol 5 dimensions) (general QoL) between baseline and day 28.
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Time frame: 28 days
Any difference in number of new brain MRI lesions at day 14 with regards to the baseline, comparing the two drugs
Time frame: 14 days
Any difference in number of new brain MRI lesions at day 28 with regards to the baseline, comparing the two drugs
Time frame: 28 days