- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674099
Imatinib for Multiple Sclerosis (MS) Relapses
Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Tomas Olsson, MD, Prof
- Phone Number: +46707213598
- Email: Tomas.Olsson@ki.se
Study Locations
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Copenhagen, Denmark, 2100
- Not yet recruiting
- Rigshospitalet
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Contact:
- FinnThorup Sellebjerg, MD
- Email: finn.thorup.sellebjerg@regionh.dk
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Hamburg, Germany, 20246
- Recruiting
- Hamburg-Eppendorf
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Contact:
- Christoph Heesen
- Email: heesen@uke.de
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Principal Investigator:
- Christoph Heesen
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Kiel, Germany, 24105
- Recruiting
- UKSH Campus Kiel
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Contact:
- Klarissa Hanja Stürner, MD
- Email: Klarissa.Stuerner@uksh.de
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Köln, Germany, 50937
- Recruiting
- Uniklinik Köln
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Contact:
- Clemens Warnke, MD
- Email: clemens.warnke@uk-koeln.de
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Bergen, Norway, 5021
- Not yet recruiting
- Haukeland sjukhus
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Contact:
- Kjell Morten Myhr, MD
- Email: kjell-morten.myhr@helse-bergen.no
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Lørenskog, Norway, 1478
- Not yet recruiting
- Akershus University Hospital
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Contact:
- Trygve Holmöy, MD
- Email: trygve.holmoy@medisin.uio.no
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Oslo, Norway, 0372
- Not yet recruiting
- Rikshospitalet, Oslo
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Contact:
- Hanne Flinstad Harbo, MD
- Email: h.f.harbo@medisin.uio.no
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Oslo, Norway, 0424
- Not yet recruiting
- Ullevåls sjukhus
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Contact:
- Elisabeth G Celius, MD
- Email: uxelgu@ous-hf.no
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Göteborg, Sweden, 41345
- Recruiting
- Neurology Sahlgrenska Hospital
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Contact:
- Jan Lycke, MD
- Email: jan.lycke@neuro.gu.se
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Linköping, Sweden, 58185
- Recruiting
- Linkoping University Hospital
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Contact:
- Charlotte Dahle, MD
- Email: Charlotte.Dahle@regionostergotland.se
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Stockholm, Sweden, 11341
- Recruiting
- Akademiskt specialistcentrum
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Contact:
- Fredrik Piehl, MD
- Phone Number: +46-851779840
- Email: Fredrik.Piehl@ki.se
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Stockholm, Sweden, 17176
- Recruiting
- Karolinska Universitetssjukhuset, Solna
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Contact:
- Tomas Olsson, MD
- Phone Number: +46707213598
- Email: Tomas.Olsson@ki.se
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Uppsala, Sweden, 75185
- Recruiting
- Uppsala University Hospital
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Contact:
- Joachim Burman, MD
- Email: joachim.burman@akademiska.se
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Stockholm
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Huddinge, Stockholm, Sweden, 14186
- Recruiting
- Karolinska Universityhospital, Huddinge
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Contact:
- Katharina Fink, MD
- Email: Katharina.Fink@sll.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
Combined (estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation.
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Imatinib
Imatinib will be administered orally one tablet (400mg) twice daily, 800mg per day for 14 consecutive days.
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Tablets 400 mg
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Active Comparator: 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.
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1 g tablets or infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional system score (FSS) change between baseline and week 12 in the most worsened FSS due to the acute relapse
Time Frame: 12 weeks
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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.
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12 weeks
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Mean expanded disability status scale (EDSS) change between baseline and day 28
Time Frame: 28 days
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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
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28 days
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Mean change in 9-hole peg test (evaluates upper limb function) between baseline and day 28
Time Frame: 28 days
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Evaluates upper limb function
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28 days
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Mean change in timed 25- walk between baseline and day 28
Time Frame: 28 days
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28 days
|
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Mean change in symbol digital modality test (SDMT) between baseline and day 28
Time Frame: 28 days
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Evaluates cognitive function, with a score range of 0 to 110, with 110 representing the best cognitive function
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28 days
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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
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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.
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28 days
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Mean change in EQ5D (EuroQol 5 dimensions) (general QoL) between baseline and day 28.
Time Frame: 28 days
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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
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28 days
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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
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14 days
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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
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28 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Protein Kinase Inhibitors
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Imatinib Mesylate
Other Study ID Numbers
- Imatinib MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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