Mintaka Multiple Sclerosis Study

Multiple sclerosis (MS) is a condition that affects the nerves of your brain and spinal cord. 

Symptoms vary depending on which areas of your brain and spinal cord are affected, so it’s difficult to know how MS will progress in each person. About 1 in 1000 New Zealanders has MS and some people are at greater risk of developing it than others. There's no cure for MS, but treatment aims to prevent relapses, ease symptoms and minimise disability. Maintaining a healthy lifestyle will give you the best chance of living well.  

There are two main types: Primary Progressive MS (PPMS), which shows steady decline from onset affecting about 10-15% of MS patients, and Secondary Progressive MS (SPMS), which develops after years of relapsing-remitting MS. In progressive MS, there's ongoing nerve damage, chronic brain inflammation, and the body's repair mechanisms fail to keep up with the damage. Common symptoms include increasing difficulty walking, problems with hand coordination, cognitive decline affecting memory and thinking speed, severe fatigue, muscle stiffness and spasms, and chronic pain. The disease typically causes gradual accumulation of disability, with many patients eventually needing walking aids or wheelchairs. Current treatments like ocrelizumab can modestly slow progression but cannot stop it - most patients continue to worsen despite treatment. 

About the investigational medication 

The investigational medication is a potential new oral medication (taken as capsules once daily) being tested as an add-on treatment to standard MS therapy. Unlike current MS treatments that mainly target the immune system, the study medication aims to work through an approach that increases the natural protective substances in the brain called endocannabinoids. These substances help reduce brain inflammation and may promote repair of damaged nerve tissue - two critical problems in progressive MS. 

All participants will continue receiving or start ocrelizumab (Ocrevus®), a proven MS treatment, ensuring everyone gets effective therapy while testing whether adding the study drug provides additional benefit.  

Taking part in the study involves firstly meeting with the research doctor to find out more about your health and to see if the study is right for you.  If you wish to take part and you are eligible, we would like to see you for regular clinic visits over a period of 3-5 years. 

At the visits, we undertake health checks which can include physical examinations and blood tests. We would like to ask you questions about your MS and monitor your health throughout the study. Other procedures may include:  

• Neurological examination  
• MRI brain scans  
• ECG’s 
• Vital signs  
• Questionnaires and quality of life assessments  
• Optional lumbar puncture for CSF samples 
• Genetic testing and other lab assessments  
• Digital health monitoring – participants must be willing to wear ankle sensor throughout duration of study to measure walking activities  

You would take the potential new medication or a placebo (looks like the investigational medicine but contains no active medication). All participants will receive the Ocrelizumab infusions, however, some will take placebo while others will take the study medication. This is because ocrelizumab is an approved, effective treatment for progressive MS. 1 in 4 participants (25%) will receive placebo instead of the study medication.  The placebo control is essential to determine if study medication truly adds benefit beyond ocrelizumab alone. 

The study medication is taken as a daily pill alongside Ocrelizumab infusions.  

The study aims to investigate the study medication and to show that it is safe, effective and well tolerated.