Division of Brain Sciences, Department of Medicine, Hammersmith Hospital Campus
Burlington Danes Building, Du Cane Road, London W12 0NN. Telephone number: 0207 7594 2855
Version 10, dated 14/06/2019
IRAS 218514
REC 17/LO/0566
An experimental medicine study to validate the 18 kD translocator protein (TSPO) as a novel neuroimmunomodulatory target in multiple sclerosis
Participant Information Sheet
Who is organising this study?
The Chief Investigator is Paul Matthews, Professor of Clinical Neuroscience and Head of the Division of Brain Sciences, Imperial College London. The Sponsor of the study is Imperial College London. The study is funded by the Medical Research Council (MRC).
What is the purpose of the study?
XBD173 is a drug which temporarily changes the activity of a protein called the 18 kD Translocator Protein (better known as TSPO) in the brain. TSPO could have a role in dampening inflammation in the brain. We would like to know whether XBD173 could be a potential treatment for patients with secondary progressive multiple sclerosis (SPMS).
Why have I been invited?
You have been invited because you have been diagnosed with SPMS or because you are a healthy volunteer.
Do I have to take part?
No, it is your choice. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. You will have as much time as you like to decide if you want to participate in the study. You are free to withdraw at any time, without giving a reason and your medical care will not be affected by that decision.
What will happen to me if I take part?
Screening (approximately 1 hour)
This will take place at the Clinical Research Facility (CRF) at the Hammersmith Hospital. If you agree to take part in the study, we will ask you some questions about your health, medical history, carry out a physical examination, vital signs, height and weight and review your notes to ensure that it is safe to enroll you. If so, we will take approximately 55 ml blood from you (around 4 tablespoons ). We will test your blood to learn what kind of TSPO gene you carry, as this affects how you might respond to these drugs. We also will perform “routine” blood tests before inviting you to take part in the study, including blood count, kidney and liver tests. When we have the results of the blood tests, we will then telephone you to let you know whether we are able to include you in the study. If your blood results show an abnormality, we may not be able to include you. However, we might invite you to come back at a later date to repeat the blood test. If it has returned to normal when we repeat it, we may then be able to include you in the study.
First study visit
Approximately 4 weeks later, we will invite you back to the CRF at the Hammersmith Hospital. We will ask you some questions about your health and perform a physical examination which will include listening to your heart and feeling your tummy. For women of childbearing age, we will also perform a urine pregnancy test. We will take another blood test of approximately 200 ml (approximately 4/5 of a cup).
After these tests, you will be given the first tablet of XBD173 to take whilst you are at the CRF, and will be monitored for at least 4 hours before you leave the CRF. During the following week you will take a further 6 tablets of XBD173.
Monitoring telephone calls
If you are a healthy volunteer and experience any adverse reaction to the drug during the study, or have any medical concerns, you can contact the Principle Investigator Dr David Owen on 07801 140 800. If you are a SPMS patient, you can call the official mobile telephone number attached to the Multiple Sclerosis clinical trials team on 07779 106 743.
Second study visit
6 days after the first visit, you will take your final dose of the study drug and we will invite you back to the CRF at the Hammersmith Hospital. We will repeat the procedures of the first study visit: we will ask you some questions about your health and perform a physical examination, perform a urine pregnancy test on women of childbearing age, and take another blood sample of approximately 200 ml (approximately 4/5 of a cup).
Reimbursement
You will be reimbursed £300 for participation in the study, as well as for reasonable travel expenses. If you do not complete the study you will be reimbursed according to how much of the study you completed.
What are the possible benefits of taking part?
The study will not benefit you.
What are the possible disadvantages and risks of taking part?
XBD173
XBD173 is a drug which was initially developed by the pharmaceutical company Novartis to treat anxiety. Novartis stopped developing XBD173 because it did not appear to relieve anxiety well. However, during the time that Novartis were testing XBD173, it was used in several research centres in Europe and the United States and given to hundreds of patients with generalised anxiety disorder and to healthy volunteers for up to 6 weeks at a time. In this study you will take one dose every morning for a week.
When XBD173 has been given to healthy volunteers in earlier studies, the most common side effects were abdominal symptoms (such as diarrhoea) and nervous system disorders (such as headache). However, these side effects were not severe, and were just as common in volunteers in the same study who only received a placebo (dummy drug) instead of XBD173.
Venous Cannulation
Insertion of a cannula (a tiny, short plastic tube into a vein) may cause brief discomfort as the cannula penetrates the skin, similar to the discomfort you have when having an injection. We will use the cannula to take blood samples during the study visit. Risks of any cannulation include minor local bleeding and bruising.
Using contraception
If you agree to participate in the study, you must use appropriate contraception during and for 7 days (one week) after participation in the study if there is a risk that you or your partner may become pregnant. This applies to both male and female participants.
The appropriate methods of contraception are:
- Complete abstinence
- Injectable progestogen
- Implants of levonorgestrel
- Estrogenic vaginal ring
- Percutaneous contraceptive patches
- Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label
- Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator’s/designee’s medical examination of the subject or review of the subject’s medical his
tory for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository)
These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label.
If you have any questions about this please ask the study nurse or doctor.
Abstinence from alcohol
You will be required to abstain from alcohol for the during of dosing. This means that you are not allowed to drink alcohol for the 7 days during which you are taking XBD173.
What if something goes wrong?
Imperial College London holds insurance policies which apply to this study. If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation. If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should contact the Chief Investigator of the study, Paul Matthews (020 7594 2855, p.matthews@imperial.ac.uk), or the study co-investigator, David Owen (020 7594 7050, d.owen@imperial.ac.uk). You can also contact the 24-hour emergency number (07779 106 743), which is an official mobile telephone number attached to the Multiple Sclerosis clinical trials team. You can also contact the Patient Advice and Liaison Service (PALS) (020 3313 0088). The normal National Health Service complaint mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial Academic Health Science Centre AHSC Joint Research Compliance Office (020 7594 1872).
What will happen if I don’t want to carry on with the study?
This research is voluntary and you are free to withdraw at any time, without giving a reason. Any stored blood or cells that can still be identified as yours will be destroyed if you wish.
If for any reason you are no longer able to consent due to ill-health we will withdraw you from the study. We will keep the data and stored blood and cells you donated and use them in the study. We will make sure you understand this when we take consent before the study begins.
What will happen if there is anything wrong with my results?
If the tests we do reveal unexpected abnormalities, we will discuss them with you and, if you allow us, we will notify your GP.
Will my taking part in this study be kept confidential?
All information that is collected about you during the course of the study will be kept confidential to the extent permitted by law. If you join the study, some parts of the data about you that is collected for the study will be looked at by authorised persons at Imperial College London. They may also be looked at by representatives of regulatory authorities and by authorised people from the Trust and other designated academic researchers. The reason for this is to check that the study is being carried out correctly. Everyone involved directly in the study has a duty of confidentiality to you as a research participant and will take efforts to ensure that nothing that could reveal your identity will be disclosed outside the research site.
What will happen to my samples?
The study information will be anonymised before they are accessed for use in research.
Anonymised means these researchers will not be able to identify you as your personal details will have been removed from the sample and information we send them. To ensure the greatest benefit from your contributions, we also may share the anonymised data with other researchers.
Your blood samples will be analysed in a facility designated by the study team. The tests performed will include looking at genes and how they are expressed in your blood cells. No one will use the genetic data to try to diagnose another disease or to identify you.
Some samples also will be sent to the Hospital laboratory to perform routine tests. Unused samples will be frozen and stored and may be used for future research, which may include sending the samples to collaborators or others who may perform analyses. Any samples sent in this way will also be anonymised.
What will happen to the results of the research study?
The results of this study will be published in a medical journal. We intend to share results from the study with you and others who are participating, but you will not be identified by name in any report or publication.
Who is organising and funding the research?
The project is organised by the Chief Investigator, Paul Matthews, who is an employee of Imperial College London. No member of the research team is being paid based on the recruitment of people for the study. The study is being funded by the Medical Research Council.
Who has reviewed the study?
This research study has been reviewed by an ethics committee – a committee of people separate from your doctor, whose primary concerns are the safety, rights and welfare of patients on this study. The West London GTAC Research Ethics Committee has reviewed and approved all written materials about this study including this information sheet.
Contact for Further Information
Please ask any questions now that you wish to. A copy of this information and of the consent forms will be given to you to keep. If any questions occur to you later, or you have other concerns or would like to discuss any aspect of the study, please contact the following persons:
Dr. David Owen (Senior Lecturer and Honorary Consultant, 07801140800) or Prof. Paul Matthews (Chief Investigator, 0207 594 2855), 5th Floor Burlington Danes, Building Hammersmith Hospital, Du Cane Road, London W12 0NN
