What is the SPI2 Study?
The SPI2 Study is a clinical research study sponsored by MedDay Pharmaceuticals. It will assess the safety and effectiveness of an investigational drug, called MD1003, in men and women with progressive MS. ‘Investigational’ means that the drug has not been approved for the treatment of MS, and is still being evaluated in clinical studies such as this one. The study will compare the investigational drug with a placebo, which looks exactly like MD1003 but contains no active ingredients.
Who can take part?
About 600 participants in approximately 70 study centres across North America and Europe will take part in this study. Not everyone will be able to join the study as several inclusion criteria must be met.
Which study drug will I receive?
Once enrolled, you will be randomly assigned to one of two study treatment groups:
- Group 1 will receive the investigational drug 3 times a day (morning, noon and evening)
- Group 2 will receive the placebo 3 times a day (morning, noon and evening)
You will have a 50% chance of receiving the investigational drug. Neither you nor the study team will know to which study group you have been assigned. This ensures that the findings from the different groups will be handled in the same way. During the treatment period, participants will receive either the investigational drug or placebo. During the extension period, all participants will receive the investigational drug only.
How long will the study last?
Your participation in the study will last up to 28 months, during which you will be expected to attend the study centre 11 times. Extra visits may be required in addition to the scheduled visits, especially when relapses occur.
- Screening period – this visit will take place up to 1 month before the treatment period
- Treatment period – if you are eligible to take part, you will be asked to attend the study centre to undergo tests and receive either the investigational drug or placebo. This part will last at least 15 months
- Extension period – once all participants complete the Month 15 visit, you will receive the investigational drug only and undergo further tests. This part will last up to 12 months
What happens during visits to the study centre?
During your visits to the study centre, the study team will ask you several questions and perform a number of tests. The purpose of these tests is to assess your health and determine how your body is responding to the study drug. The following tests and examinations will occur at different times throughout the study:
- Questions about you, your medical history, any previous and current medication you may be taking
- Physical examination
- Measurements of your blood pressure, heart rate and temperature
- Assessment of your condition and how it is affecting your life, including health-related questionnaires and a timed walk test to measure mobility and leg function
- Analysis of your physical activity – to monitor and record activity, you will be given a Fitbit Flex™ device to wear while on the study. Full instructions on its use will be provided by the study team
- Blood tests
- Urinary pregnancy test (if appropriate)
- An electrocardiogram (ECG), which measures the electrical activity of your heart
- Magnetic resonance imaging (MRI) – a technique that uses a strong magnet to create pictures of your brain
- Administration of the study drug
How do I take part?
If you are interested in taking part in the SPI2 Study, just follow these 3 steps:
- Check the criteria. Participants should:
- Be aged 18–65 years
- Be diagnosed with secondary or primary progressive MS
- Not have experienced a relapse in the past 24 months
There are additional medical criteria that must be met to qualify as a participant.
- Take the pre-qualification screener
- If you pre-qualify for the SPI2 Study, you will be referred to your nearest study centre
- Visit the study centre, where the study team will:
- Discuss the study in more detail and explain what participation would mean for you
- Talk through the potential benefits and risks of being involved in the study
- Ask questions and carry out medical tests to determine whether you are right for the study, and the study is right for you
Prior to any procedures, you must agree to and sign an Informed Consent Form. This document explains the study in detail, including potential risks and benefits, as well as your rights and responsibilities.
If you are eligible to participate, the investigational drug and all study-related care will be provided without charge. If you do decide to participate, you may withdraw from the study at any time without giving a reason.