FAQ - BIOHAVEN 3965-0014
Clinical Research FAQ
Clinical research studies are conducted to determine if potential new medications are safe and if they work. Clinical research studies are performed according to government regulations that help protect the safety and rights of study participants.
A clinical investigator is a medical researcher in charge of conducting a clinical study and ensuring the well-being of study volunteers. The investigators conducting the M-STAR study are all qualified, licensed physicians and medical specialists.
Yes, participation in any clinical research study is completely voluntary. If you decide to participate in a clinical research study, you are always free to withdraw at any time for any reason without penalty or effect on your future medical care.
Informed consent is the process of learning the key facts and details about a clinical research study. This information will be provided to you before you decide to participate, and as new information becomes available during your continued participation throughout the study. Once you have read the informed consent form and understand the details including the risks and benefits, you can decide whether or not to sign the document. The informed consent process also includes opportunities for you to ask questions about the study. No study-related procedures will take place without a signed informed consent form.
An investigational study medication or research study medication is a medication that has not yet been approved by the Food and Drug Administration (FDA) for prescription by doctors.
Information about your personal health is private and confidential. With your permission, the information you provide via the online prequalification questionnaire about your medical history and health condition will be transferred to the study doctor’s office of your choice. If you pre-qualify for the study, a representative from the study doctor’s office will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA or similar agencies in other countries participating in the study.
This clinical research study is designed to determine the safety and effectiveness of an investigational drug designed to suppress an enzyme called myeloperoxidase (MPO), believed to cause inflammation and damage to neurons in the brains of patients with MSA. The purpose of the study is to see if the investigational drug helps to slow disease progression.
You will be asked to review and sign an informed consent form prior to study participation. If you qualify and sign the informed consent form, you will be enrolled into the clinical research study. Once enrolled, you will come to the study doctor’s office for periodic visits for study exams to evaluate your general health, complete health questionnaires and discuss your multiple system atrophy symptoms for approximately 48 weeks (about 11 months).
Feel free to discuss your study-related medical care with the study doctor or staff at any time during the course of the research study. It is important to take all study medication as prescribed. A caregiver who is in contact with you at least 3 hours a week must be in attendance at each visit and must be willing to complete questionnaires and provide feedback at the study visit.
The caregiver will sign and date an informed consent form similar to the one mentioned above describing the caregiver responsibilities.
This study is being conducted by trained and qualified, licensed medical doctors throughout the United States and Europe. Biohaven Pharmaceuticals is developing the research study medication and is sponsoring this clinical research study.
If you qualify for this research study, all study-related medical care and the investigational/research study medication will be provided to you at no cost. You do not need health insurance to participate, and you may be compensated for travel expenses.
Approximately 252 MSA diagnosed patients will participate globally in the study.
You could experience side effects associated with the study medication. The study staff will discuss the known risks and potential benefits in detail with you before you decide to participate.
A placebo does not contain any active ingredients and looks the same as the study medication. The use of a placebo is important in clinical research studies because it allows researchers to determine how well the active study medication may be working. Participants will have an equal (50%, 50/50, or 1 in 2) chance of being assigned to the study drug or the placebo during the study.
Neither you nor the study doctor will be able to choose or know which study group you are in. However, the study doctor can find out if there is an emergency or if it is necessary to know for your health.
After a clinical study is complete, all of the information is collected and analyzed to help determine the study medication’s safety, effectiveness, and side effects. Please consult with your study doctor or regular healthcare provider to determine your treatment options after you have completed the study.
No. However, it is a good idea to let your doctor know that you plan to participate in this research study.
With your permission, your doctor can contact the study doctor for more information at any time.
The study doctor will not take the place of your usual doctor. You should continue to see your regular doctor for any non-study related medical care.
You may be reimbursed for patient and caregiver travel expenses. And additional accommodations may be available for patients and caregivers with difficulty traveling on their own. The study staff will provide you with additional information if you prequalify.
Biohaven Pharmaceuticals is sponsoring this clinical research study.