1 Why is the SPI2 Study being carried out?
The purpose of the SPI2 Study is to assess the safety and effectiveness of an investigational drug in men and women with progressive multiple sclerosis (MS). The results of this study will help determine whether the investigational drug is a potential treatment for MS and can go forward to be considered for approval by regulatory authorities.
2 What is the investigational drug?
MD1003 contains a vitamin called ‘biotin’. Biotin helps the body convert food into fuel, which is used to produce energy. Biotin also helps the nervous system function properly. Concentrated forms of biotin have been shown to repair the nervous system, in particular ‘myelin’ – the coating that surrounds and protects the nerve fibers which are damaged by MS. Researchers believe that MD1003 can help brain cells to survive without myelin and at the same time stimulate myelin repair, which could help restore function in people with MS and reduce or stop its progression.
3 Will there be side effects from the investigational drug?
All medications may cause side effects. The potential and known side effects of MD1003 are listed in the Informed Consent Form. If you do experience any discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be monitored continuously. The study treatment will be stopped if you or the study doctor have any concerns.
4 How will I know if I am eligible for this study?
To find out whether you can take part in the SPI2 Study, visit the Can I join? page. If you meet the criteria, take the pre-qualification screener.
If you pre-qualify for the SPI2 Study, you will be referred to your nearest study centre. At this visit, the study doctor will ask you a number of questions and perform medical tests to see whether you are right for the study and the study is right for you.
5 Where are the study centres?
There are approximately 70 study centres taking part in this study, which are located across North America and Europe. Find a participating study centre near you.
6 What if I want to leave the study early?
It is voluntary to join the study. You can leave at any time for any reason without having to explain why. You will retain the right to the same standard of care you previously received. If you do decide to leave before the end of the study, you will be invited to attend the study centre for final assessment.
7 Do I need to ask my regular doctor before participating in this study?
We encourage you to inform your regular doctor that you are taking part in this clinical research study. There are some medications that are prohibited to take while on the study and your doctor may wish to contact the study team (with your permission) to request additional information.
8 Will I have to switch doctors?
No. The SPI2 Study will provide short-term study-related care only. Clinical research studies do not provide extended or comprehensive primary health care. Your family doctor may wish to work with the study team to best determine which treatments or medications are most appropriate for you. At the end of the study, your care will return, in full, to your regular doctor.
9 Will I be compensated for my participation in this study?
You will not receive payment for taking part in this study. However, the investigational drug and all study-related care will be provided without charge. Expenses associated with taking part in this study, for instance travel to/from the study centre, may be reimbursed. Please refer to the Informed Consent Form for further details.
10 Who will have access to the information collected during the study?
Your personally identifiable information (PII: eg name and address) will not be accessible to anyone who is not directly associated with this study, except with your permission or as required by law. The Sponsor (the company carrying out the study) will not have access to any PII submitted through this website. Any information gained from this study may be used for publishing results. However, this information will be combined with other participant data and will not be used to identify participants.