Status unknownPhase 2Relapsing MSNCT036740992018-000620-34

We could not find results for this trial

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What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Imatinib

Compared with

  • Methylprednisolone

    Glucocorticoid receptor agonist

What it measured

Main measures

  • Functional system score (FSS) change in the most worsened FSS after 28 days due to the acute relapse

    28 days

    RelapsesVisionFatigueBladder, bowel and sexual function
  • 1. 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. Bo

    RelapsesFatigueBladder, bowel and sexual function

Other measures (9)

  • Functional system score (FSS) change between baseline and week 12 in the most worsened FSS due to the acute relapse

    12 weeks

    RelapsesFatigue
  • Mean expanded disability status scale (EDSS) change between baseline and day 28

    28 days

    Disability progressionFatigue
  • Mean change in 9-hole peg test (evaluates upper limb function) between baseline and day 28

    28 days

    Disability progressionArm and hand function
  • Mean change in timed 25- walk between baseline and day 28

    28 days

    Disability progressionWalking and mobility
  • Mean change in symbol digital modality test (SDMT) between baseline and day 28

    28 days

    Thinking and memory
  • Mean change in Multiple Sclerosis Impact Scale (MSIS-29; MS-specific quality of life (QoL) scale) between baseline and day 28

    28 days

    Quality of life (reported by participants)
  • Mean change in EQ5D (EuroQol 5 dimensions) (general QoL) between baseline and day 28.

    28 days

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)
  • Any difference in number of new brain MRI lesions at day 14 with regards to the baseline, comparing the two drugs

    14 days

    MRI lesions
  • Any difference in number of new brain MRI lesions at day 28 with regards to the baseline, comparing the two drugs

    28 days

    MRI lesions

Who could take part

Relapsing MS · 18 to 55

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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    History

      1. Started

        Oct 2018

      2. Main results due

        Dec 2022

      3. Finished

        Jul 2023

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