imatinib for multiple sclerosis (ms) relapses

Conditions: Multiple Sclerosis

Summary: to investigate if treatment with imatinib results in a better outcome than standard care in form of methylprednisolone(mp) after ms-associated relapses.


Eligibility criteria:
inclusion criteria: * an acute exacerbation, relapse, in persons with rrms, either newly diagnosis or on treatment with one of the long-term immunomodulatory drugs, or possible ms where the diagnosis is supported by typical mri or cerebrospinal fluid changes typical of ms (this enables inclusion of persons with a first neuroinflammatory bout, with high risk of developing ms before fulfilling the mcdonald criteria for definite ms, or high risk for developing ms in the category clinically isolated syndrome (cis)/possible ms with supporting mri lesions and/or cerebrospinal fluid aberrations suggesting intra-thecal immunoglobulin synthesis with oligoclonal bands/and/or increased free kappa light chains. the relapse should be deemed to require relapse treatment by the investigator and affect a functional domain with a minimum of grade 2. * 18-55 years of age * affection of any of the following edss sub-domains representing the targeted neurological deficit: 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, and deterioration at least one step in any of these edss domains * edss ≤ 6 before the acute exacerbation * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, if they are using effective methods of contraception during the study. acceptable birth control methods are those with a failure rate of less than 1% per year when used consistently and correctly according to ctfg, september 2014 "recommendations related to contraception and pregnancy testing in clinical trials". such methods include: 1. combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation. * oral * intravaginal * transdermal 2. progestogen-only hormonal contraception associated with inhibition of ovulation * oral * injectable * implantable 3. intrauterine device (iud) 4. intrauterine hormone-releasing system (ius) 5. bilateral tubal occlusion 6. total abstinence or vasectomized partner. exclusion criteria: * a pseudo-relapse should be excluded, as deemed by the experienced treating neurologist, and as evidenced by an active infection, likely with fever, with reappearing new signs and symptoms in a previously affected neurological function. * inability to provide informed consent * concomitant medication with drugs which may increase the plasma concentration of imatinib - ketoconazole, itraconazole , erythromycin and clarithromycin * concomitant medication with drugs which may decrease the plasma concentration of imatinib: dexamethasone, phenytoin, carbamazepin, rifampicin, phenobarbital, fosphenytoin, primidon, hypericum perforatum (st john's wort). * female patients with childbearing potential, if pregnancy cannot be excluded by pregnancy test (urine point-of-care pregnancy test). * patient is participating in other interventional study * general infection or any other condition judged by the treating neurologist to contra-indicate imatinib * any laboratory deviation of general bodily functions such as kidney, or renal function judged to be of clinical significance by the treating neurologist constitutes an exclusion criteria. * patients with a positive hepatitis b-dna test result or serology indicating latent infection.

Keywords: multiple sclerosis relaps imatinib methylprednisolone