Multiple SclerosisPhase 2NCT03674099
Imatinib for Multiple Sclerosis (MS) Relapses
A Phase 2 study testing Imatinib Mesylate and Methylprednisolone in people with Multiple Sclerosis, run by Tomas Olsson at 14 sites in 4 countries.
Trial summary
To investigate if treatment with Imatinib results in a better outcome than standard care in form of Methylprednisolone(MP) after MS-associated relapses. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Imatinib Mesylate and Methylprednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 1 Oct 2018to 30 Jul 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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:
- Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
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- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- total abstinence or vasectomized partner.
Who cannot join
- 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
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- 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.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
Sweden6 sites, 6 recruiting
- Recruiting
Neurology Sahlgrenska Hospital
Gothenburg, 41345
Jan Lycke, MD, jan.lycke@neuro.gu.se
- Recruiting
Karolinska Universityhospital, Huddinge
Huddinge, Stockholm County, 14186
Katharina Fink, MD, Katharina.Fink@sll.se
- Recruiting
Linköping University Hospital
Linköping, 58185
Charlotte Dahle, MD, Charlotte.Dahle@regionostergotland.se
- Recruiting
Akademiskt specialistcentrum
Stockholm, 11341
Fredrik Piehl, MD, +46-851779840, Fredrik.Piehl@ki.se
- Recruiting
Karolinska Universitetssjukhuset, Solna
Stockholm, 17176
Tomas Olsson, MD, +46707213598, Tomas.Olsson@ki.se
- Recruiting
Uppsala University Hospital
Uppsala, 75185
Joachim Burman, MD, joachim.burman@akademiska.se
Norway4 sites, 4 recruiting
- Not yet recruiting
Haukeland sjukhus
Bergen, 5021
Kjell Morten Myhr, MD, kjell-morten.myhr@helse-bergen.no
- Not yet recruiting
Akershus University Hospital
Lørenskog, 1478
Trygve Holmöy, MD, trygve.holmoy@medisin.uio.no
- Not yet recruiting
Rikshospitalet, Oslo
Oslo, 0372
Hanne Flinstad Harbo, MD, h.f.harbo@medisin.uio.no
- Not yet recruiting
Ullevåls sjukhus
Oslo, 0424
Elisabeth G Celius, MD, uxelgu@ous-hf.no
Germany3 sites, 3 recruiting
- Recruiting
Uniklinik Köln
Cologne, 50937
Clemens Warnke, MD, clemens.warnke@uk-koeln.de
- Recruiting
Hamburg-Eppendorf
Hamburg, 20246
Christoph Heesen, heesen@uke.de
Christoph Heesen
- Recruiting
UKSH Campus Kiel
Kiel, 24105
Klarissa Hanja Stürner, MD, Klarissa.Stuerner@uksh.de
Denmark1 site, 1 recruiting
- Not yet recruiting
Rigshospitalet
Copenhagen, 2100
FinnThorup Sellebjerg, MD, finn.thorup.sellebjerg@regionh.dk
About this study
Official title: Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study
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
- Being tested
- Imatinib Mesylate, Methylprednisolone
- Keywords
- Multiple Sclerosis relaps, Imatinib, Methylprednisolone
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imatinib MesylateDrug
Tablets 400 mg
1 g tablets or infusion
| Study group | Role | What they receive |
|---|---|---|
| Imatinib | Experimental | Imatinib will be administered orally one tablet (400mg) twice daily, 800mg per day for 14 consecutive days. Receives: Drug: Imatinib Mesylate |
| Methylprednisolone | Active comparator | 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. Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional system score (FSS) change in the most worsened FSS after 28 days due to the acute relapse
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. Bowel and Cerebral domains will not be considered in the primary endpoints. The FSS is graded accordingly: 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 6. bowel/bladder function 7. Cerebral functions
Measured: 28 days
Secondary outcomes (9)
Functional system score (FSS) change between baseline and week 12 in the most worsened FSS due to the acute relapse
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.
Measured: 12 weeks
Mean expanded disability status scale (EDSS) change between baseline and day 28
Calculation of EDSS summary score is based on the FSS score, from 0-5 with 0 representing normal neurological exam and 10 representing death by MS
Measured: 28 days
Mean change in 9-hole peg test (evaluates upper limb function) between baseline and day 28
Evaluates upper limb function
Measured: 28 days
Mean change in timed 25- walk between baseline and day 28
Measured: 28 days
Mean change in symbol digital modality test (SDMT) between baseline and day 28
Evaluates cognitive function, with a score range of 0 to 110, with 110 representing the best cognitive function
Measured: 28 days
Mean change in Multiple Sclerosis Impact Scale (MSIS-29; MS-specific quality of life (QoL) scale) between baseline and day 28
The MISIS-29 consists of 29 items (composed of 20- item physical scale and a 9-item psychological scale), graded from 1-5 points with 5 indicating the most severe impact. The points for the two scales are individually summarized. The physical scale results in a sum with a range 20-100 , where 100 indicates the worse health. The psychological scale is similarly resulting in a range between to 9- 45, where 9 is the least and 45 is the worst.
Measured: 28 days
Mean change in EQ5D (EuroQol 5 dimensions) (general QoL) between baseline and day 28.
EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 28 days
Any difference in number of new brain MRI lesions at day 14 with regards to the baseline, comparing the two drugs
Measured: 14 days
Any difference in number of new brain MRI lesions at day 28 with regards to the baseline, comparing the two drugs
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single-blinded, controlled.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Olsson
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor-investigator, Tomas Olsson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674099
- Sponsor's protocol ID
- Imatinib MS
- Status last verified
- Jul 2021
- First submitted
- 14 Sep 2018
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study
- ClinicalTrials.gov ID
- NCT03674099
- Acronym / sponsor ID
- Imatinib MS
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis relaps, Imatinib, Methylprednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tomas OlssonUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate if treatment with Imatinib results in a better outcome than standard care in form of Methylprednisolone(MP) after MS-associated relapses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single-blinded, controlled.
| Arm | Type | Receives |
|---|---|---|
| Imatinib | Experimental | Drug: Imatinib MesylateImatinib will be administered orally one tablet (400mg) twice daily, 800mg per day for 14 consecutive days. |
| Methylprednisolone | Active comparator | Drug: MethylprednisoloneMethylprednisolone 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imatinib MesylateTablets 400 mg | Drug | Imatinib |
| Methylprednisolone1 g tablets or infusion | Drug | Methylprednisolone |
Primary outcome
Functional system score (FSS) change in the most worsened FSS after 28 days due to the acute relapse
Time frame: 28 days
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. Bowel and Cerebral domains will not be considered in the primary endpoints. The FSS is graded accordingly: 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 6. bowel/bladder function 7. Cerebral functions
9 secondary outcomes
Functional system score (FSS) change between baseline and week 12 in the most worsened FSS due to the acute relapse
Time frame: 12 weeks
Mean expanded disability status scale (EDSS) change between baseline and day 28
Time frame: 28 days
Mean change in 9-hole peg test (evaluates upper limb function) between baseline and day 28
Time frame: 28 days
Mean change in timed 25- walk between baseline and day 28
Time frame: 28 days
Mean change in symbol digital modality test (SDMT) between baseline and day 28
Time frame: 28 days
Mean change in Multiple Sclerosis Impact Scale (MSIS-29; MS-specific quality of life (QoL) scale) between baseline and day 28
Time frame: 28 days
Mean change in EQ5D (EuroQol 5 dimensions) (general QoL) between baseline and day 28.
Time frame: 28 days
Any difference in number of new brain MRI lesions at day 14 with regards to the baseline, comparing the two drugs
Time frame: 14 days
Any difference in number of new brain MRI lesions at day 28 with regards to the baseline, comparing the two drugs
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib Mesylate and Methylprednisolone in people with Multiple Sclerosis, run by Tomas Olsson at 14 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Sweden, Norway, Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomas Olsson, MD, Prof (+46707213598, Tomas.Olsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional system score (FSS) change in the most worsened FSS after 28 days due to the acute relapse (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.