What started with a slight hand tremor or unsteadiness while walking turned into a Parkinson’s disease diagnosis. That’s when anxiety about the future set in. Your doctor has discussed the treatment options, but you may not have started taking any medication yet.
The Luminare Studies are evaluating the safety and efficacy of a study drug, as compared to a placebo, to see if it may delay the progression of Parkinson’s disease in people who are in the early stage of their condition.
The study drug is thought to lower the activity of a protein in your body that may be responsible for symptoms of Parkinson’s disease. In the clinical trials, the study drug is a tablet taken by mouth once daily.
You may be eligible to participate if you:*
Are 30-80 years old
Were diagnosed with Parkinson’s disease within the last 2 years and were at least 30 years old when you were diagnosed
Other eligibility criteria apply
You should know that participant safety is our number one priority during every stage of the study process. All research studies are carefully supervised, monitored, and documented. Every research study is reviewed and approved by a special group of people called an Institutional Review Board (IRB) or Ethics Committee (EC), which is made up of scientists, nonscientist professionals, and members of the public. They also make sure that participants’ rights are protected, and they seek to avoid exposure to unnecessary risks. IRBs and ECs will approve only studies that they think could help answer important medical questions.
While the study is ongoing, a team of study doctors and nurses at the study site will closely monitor your health. If you have questions or concerns at any point throughout the study, a study staff member is available. The study staff can also tell you about their COVID-19 safety protocols.
Your participation is voluntary, and you are free to withdraw at any time, for any reason. Although others can help you make up your mind, the final decision is yours to make. Your privacy will be maintained throughout the study.
Parkinson's disease is a movement disorder that impacts the central nervous system. It is a progressive disease, which means the symptoms get worse over time.1,2
Symptoms may include:2
Tremor (involuntary shaking or movement)
Bradykinesia (slowness of movement)
Balance problems and difficulty walking
Other symptoms may include sleep difficulties, constipation, depression, and anxiety.1
The cause of Parkinson's disease is not known, though it is believed that environmental and genetic factors may play a role.3 Although there is no cure, treatment options are available.2
Most people develop symptoms after the age of 50, but it’s estimated that 4% to 10% are diagnosed before the age of 50.1,4 Men are 1.5 times more likely than women to have this condition.4
What is Parkinson’s disease? American Parkinson Disease Association. Accessed March 17, 2022. https://www.apdaparkinson.org/what-is-parkinsons
What is Parkinson’s? Parkinson’s Foundation. Accessed March 17, 2022. https://www.parkinson.org/understanding-parkinsons/what-is-parkinsons
Causes [of Parkinson’s disease]. Parkinson’s Foundation. Accessed March 17, 2022. https://www.parkinson.org/Understanding-Parkinsons/Causes
Statistics [on Parkinson’s disease]. Parkinson’s Foundation. Accessed March 17, 2022. https://www.parkinson.org/Understanding-Parkinsons/Statistics
The purpose of the Luminare Studies is to evaluate the safety and efficacy of an investigational drug, as compared to a placebo, to see if it may delay the progression of Parkinson’s disease in eligible patients who are in the early stage of their condition. A placebo is a substance that looks like the investigational drug, but does not have active drug.
Biogen, in collaboration with Denali Therapeutics Inc., is conducting the Luminare Studies. Biogen is a global biotechnology company located in Cambridge, Massachusetts. Denali Therapeutics is a biopharmaceutical company based in South San Francisco, California.
The Luminare Studies will be conducted globally. When you take the prescreener, we use your zip code to locate a study site in your area.
Deciding to participate in a research study is an important and personal decision. Before you agree to participate, the study team will review all aspects of the research study with you, and if you wish, your loved one. You will be given a document called an Informed Consent Form that provides, in writing, the research study's purpose, medical measurements that will be done, procedures, potential benefits, risks, and precautions. You will have the opportunity to ask questions and are encouraged to speak with family and your own physician to decide if taking part is right for you.
Additionally, your participation in the study is completely voluntary. You may withdraw from the study at any time, for any reason, without impact to your regular medical care.
Study-related medical care and study medication will be provided at no cost. You may be compensated for some of your transportation and other costs related to the study. The study staff can provide you with more information about this.
Yes. There is a 1 in 2 chance of receiving a placebo during this study. A placebo is a substance that looks like the investigational drug but contains no active medication. A placebo helps to differentiate any changes seen during the study and determine whether they are due to the study medication alone and not another reason.
There is also a 1 in 2 chance that you will receive the investigational drug. Your treatment group will be assigned at random (by chance), so neither you nor the study team will know which one you are receiving. However, in case of an emergency, the study doctor can quickly find out.
The information you provide will be kept confidential in a secure database and used to evaluate your qualification for this study only. With your permission and if you meet the prescreening criteria, we will forward your contact information and online prescreener answers to the study site you selected. If you do not meet the prescreening criteria, all information regarding your identification will be deleted from our database, unless you authorize us to contact you in the future. Your information is not shared with any third-party organization for any separate use or shared with anyone who is not directly associated with this clinical research study without your permission (except as required by law) or as set forth in the informed consent. You can read or download a copy of our full data privacy notice at https://www.biogen.com/en_us/privacy-policy.html.
No, your doctor does not have to give you permission to participate. However, feel free to talk to your doctor about participating in the study. With your permission, the study doctor will keep your regular doctor updated about your condition during the study.
Yes, your participation in any research study is completely voluntary. If you decide to participate in a research study, you are always free to withdraw at any time, for any reason, without any penalty or effect on your future medical care. You should talk to your study doctor about leaving the study so that a final evaluation can be scheduled.
In the context of the Luminare Studies, a research study, also known as a clinical trial, is a scientific study that evaluates the safety and efficacy of an investigational drug, as compared to a placebo. A placebo is a substance that looks like the investigational drug, but does not have active drug. Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.
It is only through the completion of research studies that investigational drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries, such as the US Food and Drug Administration (FDA), may provide this approval after a thorough review. Today, prescription medications need to be shown to be generally safe and effective during research studies.
To help make sure that a clinical research study is ethical, and that participants’ rights are protected, Institutional Review Boards (IRBs) or Ethics Committees (ECs) review study protocols.
Only people who meet all required eligibility criteria for a research study may take part. The study team at the study doctor’s office will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the research study. You may also be asked to provide information from your medical records to help the study team determine whether you may be eligible.
An investigational drug is a drug being studied that has not been approved by the U.S. Food & Drug Administration as its safety and efficacy have not been established. Before a clinical research study ever allows people to join, it must go through initial reviews and approvals by organizations and agencies like the U.S. FDA; the Institutional Review Board, or IRB; and Ethics Committee, or EC. The IRB and EC consist of scientists, physicians, and community members to make sure the research is ethical and the rights of people in the study are protected.