Yes, you can visit any doctor to meet your health needs during the clinical trial. You should let your study doctor know that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical trial.
You can ask your study team questions at any time before, during, and after the FUSION study. Before agreeing to participate, the study team will review the Informed Consent Form (ICF) to help you understand what participation in the study will involve. If you have any concerns about participating in the clinical trial, you should feel comfortable discussing them with a member of the study team at any time.
There is no cost associated with participation in the study. Travel expenses (such as transportation and hotel, if required) will be provided. You may also be reimbursed for certain travel expenses.
There are always risks involved in participating in clinical studies. The side effects of new drugs or devices are not fully understood, which is part of the reason the research is being done. However, clinical study protocols are carefully controlled and designed to monitor the safety of all the participants. In addition, investigational drugs and devices go through extensive pre-clinical testing before they even make it into a clinical study. All clinical study protocols must be reviewed by an Institutional Review Board, or IRB, which may be comprised of doctors, nurses, and/or medical ethics experts, whose job it is to review the study and ensure the potential benefits outweigh the risks.
Participating in a clinical study allows researchers to gather valuable information about potential new therapies for medical conditions. In some cases, the medical conditions are extremely rare and have limited or no available treatments. Participating in a clinical study may enable a patient to take a more active role in their own healthcare or a chance to gain access to new investigational drugs or devices before they are available, and the information gathered from these studies may help others with the same disease or condition in the future.
A clinical trial is a medical research study designed to assess whether or not a new drug or treatment is well-tolerated and effective in treating people with a particular disease.
Participating in the trial will not cost you anything and all study participants will be reimbursed for all travel related to the FUSION study.
During the FUSION study, your health is our number one priority. All medical guidelines are to be followed in study clinics, including the use of gloves, properly prepping needles, and disposing of all materials. Masks, safety goggles, or face shields may also be used for added protection.
If you are eligible and agree to participate in the FUSION study, you will either receive the investigational antisense medicine or placebo during the first part of the treatment period. A placebo is a substance that looks like and is taken the same way as the real potential treatment, but has no active ingredients or medical benefit. Everyone will receive the investigational antisense medicine in Part 2 of the FUSION study.
In clinical trials, a placebo is given to some participants so that the two groups-for FUSION, it is those taking the investigational antisense medicine vs. those taking the placebo-can be compared to show whether the potential treatment being studied is safe and is effective. A placebo can also help researchers determine whether certain changes during the FUSION study happen by chance or actually in response to the treatment.
The screening period will help determine your eligibility to participate, make general and disease-specific health assessments, and provide baseline testing results to compare with the end of treatment. You will also have physical examinations and laboratory tests, if needed, to make sure you are healthy enough and ready to participate. These include, but are not limited to, an ECG, an MRI, and a genetic test to confirm a mutation of the FUS gene.
Because this is a research study, if, after you have completed some or all of the examinations required during the screening period, you may or may not be eligible to participate in the FUSION study.