Imatinib for Multiple Sclerosis (MS) Relapses

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Recruiting
days left to enroll

59
participants needed

200
sponsor

Tomas Olsson

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Updated on 14 February 2022

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MRI

methylprednisolone

clinically isolated syndrome

oligoclonal bands

Summary

To investigate if treatment with Imatinib results in a better outcome than standard care in form of Methylprednisolone(MP) after MS-associated relapses.

Details

Condition	Multiple Sclerosis
Treatment	Imatinib Mesylate, Methylprednisolone
Clinical Study Identifier	NCT03674099
Sponsor	Tomas Olsson
Last Modified on	14 February 2022

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Eligibility		Yes	No	Not Sure
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
	-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
	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

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Imatinib for Multiple Sclerosis (MS) Relapses