At Biogen, we’re looking to develop treatments that could potentially slow the progression of ALS.
Our studies are focused on both genetic forms of ALS as well as ALS with no known genetic association. We are conducting trials in people who have been diagnosed with ALS as well as with people who have certain mutations associated with ALS, but do not currently display any signs or symptoms of disease.
Before you join a trial, we first confirm your eligibility with some health assessments. Then, if you’re eligible and choose to take part in an ALS trial, you’ll need to attend several appointments so that the trial team can closely monitor your health and condition with health assessments, such as:
These can tell us about many things, such as how your blood is clotting, whether you have any illnesses that we need to know about, to confirm you have a genetic mutation related to ALS, and to see how certain levels may be affected by the investigational drug.
Lumbar punctures involve inserting a needle between the bones of the spine in your lower back, in order to take a small amount of cerebrospinal fluid (fluid surrounding the brain and spinal cord). The trial doctor will discuss any risks associated with this procedure with you, including, but not limited to: headache and back discomfort/pain.
Various tests may be performed to check your muscle health (for example, by placing sensors on the skin), how your muscles are working (e.g, by passing an electrical current through them), and how strong they are (e.g., by pressing a device against your arms and legs to see if you can resist the pressure).
Other assessments will be involved. A full list of these, and all other requirements around taking part in a trial, would be fully discussed with you before you made a decision about whether to join a trial or not.
ALS trials are designed to take up as little of your time as possible, and there may be assistance available (e.g., reimbursement for travel costs) to help you get to and from the trial site to make it as easy as possible for you to participate.
Someone who cares for you, for example a partner, sibling, other family member, close friend, or professional caregiver, may need to help you in order for you to take part in the trial. This may be to help you get to and from your appointments and support you throughout the trial. Or, they might be asked to help monitor any changes in your condition and report them to us. Visit our section on caregivers for more information about this role.
When researching potential new treatments for diseases, trials must compare the investigational drug with something else in order to prove its effect. That’s why many ALS trials will have one or more groups of people taking the investigational drug and another group taking a placebo.
In some trials, participants – assigned to receive either the investigational drug or the placebo – may continue with their standard of care therapies
To find new treatments options for ALS, we must first test investigational drugs in clinical trials. But in the same way that diseases like ALS can impact groups of people in different ways, how medicine works in the body can also vary for different groups of people. That’s why it’s so important that a diverse range of people take part in clinical trials.
You can learn more about the importance of diversity in clinical trials, and Biogen’s efforts to make an impact, here.