Imatinib for Multiple Sclerosis (MS) Relapses

NCT ID: NCT03674099

Last Updated: 2021-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2023-07-30

Brief Summary

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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Imatinib

Imatinib will be administered orally one tablet (400mg) twice daily, 800mg per day for 14 consecutive days.

Group Type: EXPERIMENTAL

Imatinib Mesylate

Intervention Type: DRUG

Tablets 400 mg

Methylprednisolone

Methylprednisolone will be administered once a day either in tablets; Medrol 1g per day or iv; Solumedrol 1000 mg per day, both for three consecutive days.

Group Type: ACTIVE_COMPARATOR

Methylprednisolone

Intervention Type: DRUG

1 g tablets or infusion

Interventions

Imatinib Mesylate

Tablets 400 mg

Intervention Type: DRUG

Methylprednisolone

1 g tablets or infusion

Intervention Type: DRUG

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
• Patients with a positive Hepatitis B-DNA test result or serology indicating latent infection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Tomas Olsson

OTHER

Sponsor Role: lead

Responsible Party

Tomas Olsson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: NOT_YET_RECRUITING

Uniklinik Köln

Cologne, , Germany

Site Status: RECRUITING

Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

UKSH Campus Kiel

Kiel, , Germany

Site Status: RECRUITING

Haukeland sjukhus

Bergen, , Norway

Site Status: NOT_YET_RECRUITING

Akershus University Hospital

Lørenskog, , Norway

Site Status: NOT_YET_RECRUITING

Rikshospitalet, Oslo

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Ullevåls sjukhus

Oslo, , Norway

Site Status: NOT_YET_RECRUITING

Karolinska Universityhospital, Huddinge

Huddinge, Stockholm County, Sweden

Site Status: RECRUITING

Neurology Sahlgrenska Hospital

Gothenburg, , Sweden

Site Status: RECRUITING

Linköping University Hospital

Linköping, , Sweden

Site Status: RECRUITING

Akademiskt specialistcentrum

Stockholm, , Sweden

Site Status: RECRUITING

Karolinska Universitetssjukhuset, Solna

Stockholm, , Sweden

Site Status: RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Denmark; Germany; Norway; Sweden

Central Contacts

Tomas Olsson, MD, Prof

Role: CONTACT

Tomas.Olsson@ki.se

+46707213598

Facility Contacts

FinnThorup Sellebjerg, MD

Role: primary

finn.thorup.sellebjerg@regionh.dk

Clemens Warnke, MD

Role: primary

clemens.warnke@uk-koeln.de

Christoph Heesen

Role: primary

heesen@uke.de

Klarissa Hanja Stürner, MD

Role: primary

Klarissa.Stuerner@uksh.de

Kjell Morten Myhr, MD

Role: primary

kjell-morten.myhr@helse-bergen.no

Trygve Holmöy, MD

Role: primary

trygve.holmoy@medisin.uio.no

Hanne Flinstad Harbo, MD

Role: primary

h.f.harbo@medisin.uio.no

Elisabeth G Celius, MD

Role: primary

uxelgu@ous-hf.no

Katharina Fink, MD

Role: primary

Katharina.Fink@sll.se

Jan Lycke, MD

Role: primary

jan.lycke@neuro.gu.se

Charlotte Dahle, MD

Role: primary

Charlotte.Dahle@regionostergotland.se

Fredrik Piehl, MD

Role: primary

Fredrik.Piehl@ki.se

+46-851779840

Tomas Olsson, MD

Role: primary

Tomas.Olsson@ki.se

+46707213598

Joachim Burman, MD

Role: primary

joachim.burman@akademiska.se

Other Identifiers

Imatinib MS

Identifier Type: -

Identifier Source: org_study_id