Imatinib for Multiple Sclerosis (MS) Relapses

Inclusion Criteria:

• An acute exacerbation, relapse, in persons with RRMS, either newly diagnosis or ontreatment with one of the long-term immunomodulatory drugs, or possible MS where thediagnosis is supported by typical MRI or cerebrospinal fluid changes typical of MS (this enables inclusion of persons with a first neuroinflammatory bout, with high riskof developing MS before fulfilling the McDonald criteria for definite MS, or high riskfor developing MS in the category clinically isolated syndrome (CIS)/possible MS withsupporting MRI lesions and/or cerebrospinal fluid aberrations suggesting intra-thecalimmunoglobulin synthesis with oligoclonal bands/and/or increased free Kappa Lightchains. The relapse should be deemed to require relapse treatment by the investigatorand 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 targetedneurological 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. Sensoryfunction 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 ofbecoming pregnant, if they are using effective methods of contraception during thestudy. 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 associatedwith 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 treatingneurologist, and as evidenced by an active infection, likely with fever, withreappearing 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 ofImatinib - ketoconazole, itraconazole , erythromycin and clarithromycin
• Concomitant medication with drugs which may decrease the plasma concentration ofImatinib: dexamethasone, phenytoin, carbamazepin, rifampicin, phenobarbital,fosphenytoin, primidon, Hypericum perforatum (St John's wort).
• Female patients with childbearing potential, if pregnancy cannot be excluded bypregnancy 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 tocontra-indicate Imatinib
• Any laboratory deviation of general bodily functions such as kidney, or renal functionjudged to be of clinical significance by the treating neurologist constitutes anexclusion criteria.
• Patients with a positive Hepatitis B-DNA test result or serology indicating latentinfection.