• Principal Investigator:  Dr Stella Hughes, Consultant Neurologist, Belfast HSC Trust.

• Name of the Study: Cladribine to halt deterioration in people with advanced multiple sclerosis, CHARIOT MS.
  
  
  
• Short name: CHARIOT MS.

• Why is this important?
  
  Multiple Sclerosis (MS) is a chronic inflammatory and degenerative disease of the central nervous system affecting more than 120,000 people in the UK. Without treatment, people diagnosed with MS will develop significant disability within 10 years of onset. Currently, treatment is withdrawn or withheld from people with an Expanded Disability Status Scale (EDSS) of more than 6.5 (requires two walking aids - to walk 20m without resting) due to the belief that the condition will no longer respond to treatment. Over the past few years evidence has been produced suggesting people even at a more advanced stage of MS may still benefit from treatment.
  

• What is the Research question / aim?
  
  We think that Cladribine tablets (MAVENCLAD^®) have the potential to protect upper limb function in people with advanced MS (pwAMS). Based on a strong scientific rationale, ChariotMS will be the first trial to address this significant unmet health need, focusing on people with MS with an EDSS of 6.5 - 8.5. If successful, ChariotMS will provide evidence to inform the NHS adoption of Cladribine tablets as a treatment for pwAMS.
  
  Protecting upper limb (and other neurological) function will help pwAMS to maintain their independence for longer. This would not only have a major impact on the lives of pwAMS, but also their family, carers and on medical and social services.
  
  About 200 pwAMS will take part in this UK-wide study. If you agree to participate, you will be in the study for approximately 24 months; this includes the time that you will receive treatment and the follow up visits.
  
  We are aiming to:
  
  - Test the safety of Cladribine tablets in pwAMS
  - See how well Cladribine tablets, compared to placebo, work in protecting upper limb function
  - Determine the cost effectiveness of using Cladribine tablets in pwAMS.
  - Gain further information in the mechanism by which Cladribine tablets act in pwAMS.
  - To see how effective Cladribine tablets are in preventing loss of brain volume, loss of spinal cord cross sectional area and to see     whether there are any new lesions.

• What the Study involves: 
  
  The study involves attendance of 8 face to face visits over 2 years as well as the following:
  
  - A physical examination
  - An Expanded Disability Status Scale (EDSS) assessment
  - Your height, weight and vital signs
  - ECG (a routine test to check your heart)
  - Hand and finger function tests - 9 Hole peg test (9-HPT) and ARAT Test
  - Lower limb function test - Timed 25-foot walk test (T25FW)
  - The Symbol Digit Modalities Test (SDMT)
  - Visual function test - Sloane Low Contract Visual Acuity Test (SLCVA)
  - MS specific questionnaires including ABILHAND-56, MSIS-29 v2 and Neurological Fatigue Index (NFI-MS)
  - Blood test where we will collect up to 6 blood samples
  - MRI Scan
  
  PPI Involvement:
  
  We have received input from various areas of the MS community including people with advanced MS themselves (through patient and public involvement (PPIR) groups). They have provided input into the research proposal, study procedures and patient documents, and will continue to support the progress of this study. There will also be on person with advanced MS on the trial steering committee to ensure as many voices as possible are heard in how the trial is managed throughout its life.

• Who can take part in the Study?
  
  People with advanced MS who score between 6.5 and 8.5 on the Expanded Disability Status Scale (EDSS), and who are not currently on a Disease modifying treatment for MS.

• Contact Information:
  
  - Name: Mrs Fiona Magill, MS Research Nurse
  
  - Email: fiona.magill@belfasttrust.hscni.net 
  
  - Phone: 028 950 42252

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