Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Seema Kalra
+44 17 82715444
Seema.Kalra@uhnm.nhs.uk


Dr Maria Carvalho
+33 (0) 970 71 62 49
maria.carvalho@ab-science.com


Study Location:

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Be Part of Research - Trial Details - Masitinib in patients with primary progressive or secondary progressive multiple sclerosis
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Masitinib in patients with primary progressive or secondary progressive multiple sclerosis

Recruiting

Open to: All Genders

Age: Adult

Stoke-on-trent Salford

Medical Conditions

Multiple sclerosis

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Multiple sclerosis (MS) is an inflammatory neurodegenerative disease of the central nervous system (CNS). The vast majority of MS drugs primarily benefit active/relapsing forms of MS with limited efficacy in the progressive forms. It is estimated that 10-15,000 people have primary progressive MS in the UK.
Masitinib is a new chemical entity under development in progressive forms of multiple sclerosis. Masitinib targets newly discovered disease mechanisms via its dual action against activated macrophage/microglia and mast cells.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

31 Mar 2022 01 Jun 2026

Patients will be treated for 96 weeks with masitinib or placebo. They will be then offered the option to participate in open-label extension. As part of the study, patients will have a physical exam, vital signs, and neurological exam. They will have efficacy assessments and questionnaires to evaluate their medical condition and its progress. Patients will have ECGs to monitor cardiac safety and also routine blood samples and PK blood samples. There will be urinalysis and urine cytology. For some patients there will be regular permanency testing.


Patients with primary and secondary progressive MS without relapse will be eligible to be treated during the study.

You can take part if:



You may not be able to take part if:


1. Patients suffering from a disease other than MS that would better explain the patient’s neurological clinical signs and symptoms and/or MRI lesions observed at screening 2. Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic 3. Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline 4. Patients with lymphocytes <1.0 × 10^9/L at screening and at baseline


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Royal Stoke University Hospital
    Newcastle Road
    Stoke-on-trent
    ST4 6QG
  • Salford Royal Hospital
    Stott Lane Eccles
    Salford
    M6 8HD

Benefits:
Participants will be reimbursed for their travel expenses upon presentation of costs' proofs.
Risks:
Masitinib is an experimental drug and there could be adverse events that are not known yet. This is why participants will be monitored closely throughout the study. Participants will need to attend regular clinic visits which could be a burden but this is the only option to monitor their safety and well-being.

Dr Seema Kalra
+44 17 82715444
Seema.Kalra@uhnm.nhs.uk


Dr Maria Carvalho
+33 (0) 970 71 62 49
maria.carvalho@ab-science.com



The study is sponsored by Dokumeds and funded by AB Science.




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What will you do next?
Read full details for Trial ID: ISRCTN93303620

Or CPMS 52039

Last updated 07 June 2022

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.   

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