MULTIPLE SYSTEM ATROPHY (MSA)
The MASCOT trial is evaluating an investigational trial drug designed to slow MSA progression.
Our team of medical professionals is evaluating an investigational trial drug that potentially may delay disease progression in patients living with multiple system atrophy (MSA). If you or someone you care for has been diagnosed with MSA, you (or they) may qualify for the trial.
Learn more about the MASCOT Trial and whether it is right for you!
The MASCOT Trial is helping to determine whether the investigational trial drug (Lu AF82422) is effective and safe in slowing the disease progression in people living with MSA.
If you qualify for the MASCOT Trial, you will be randomly (by chance) chosen to receive either the investigational trial drug or placebo (inactive medication). Out of approximately 360 participants, about 240 will receive the investigational trial drug and about 120 will receive the placebo.
- Investigational trial drug group (2/3 chances to be in the trial drug dosing group)
- Placebo drug group (1/3 chances to be in this group). The placebo looks just like the investigational trial drug, but has no active ingredient.
The investigational trial drug (or placebo) is given by intravenous (IV, or through a vein) infusion once every 4 weeks.
You may be eligible to join if you:
- Are 40 to 75 years of age
- Have been diagnosed with MSA and it has been less than 5 years from the onset of MSA symptoms related to abnormal body movement
- Have a reliable caregiver who will be available throughout the trial to complete caregiver observer questionnaires (during a site visit)
- A caregiver, for the purposes of this trial, should be a person who usually spends approximately 3 hours or more with you per week and is able to help talk to the trial team about your symptoms
Other requirements need to be met to be eligible to join the MASCOT Trial. Please find a trial site near you and contact us for details.
Global Trial Locations
These are the locations of the centres where the MASCOT Trial will be conducted and that are supporting this website. The trial centres will be onboarded on an ongoing basis. Not all centres may be currently recruiting.
These are the locations of the centers where the MASCOT Trial will be conducted and that are supporting this website. The trial centers will be onboarded on ongoing basis. Not all centers may be currently recruiting.
These are the locations of the centers where the MASCOT Trial will be conducted and that are supporting this website. The trial centers will be onboarded on ongoing basis. Not all centers may be currently recruiting.
The trial lasts 2 or more years, depending on whether you remain in the optional, open-label extension treatment period, with this breakdown:
- Screening period, to determine whether you qualify (3 to 6 weeks)
- Placebo-controlled period, when 2/3 participants will receive the investigational trial drug and 1/3 participants will receive the placebo (72 weeks)
- Optional, open-label period, when all participants (even those who were receiving the placebo) receive the investigational trial drug (72 weeks)
- Safety follow-up period (20 weeks from the last dose of the investigational trial drug)
There are between 20 and 38 scheduled visits to the trial centre (depending on whether you remain in the open-label treatment period).
Clinical research trials are needed to determine whether an investigational drug is safe and effective to treat a particular condition or group of patients.
During these trials, information is collected on the effects of the investigational drug being taken. Once a clinical research trial is completed, the sponsor of the trial carefully evaluates the data and may decide to submit an application for the approval of the investigational drug to regulatory agencies. Depending on the data submitted, the regulatory agencies may decide to approve the investigational drug for use.
There are guidelines and regulations that must be followed during clinical research trials to help protect the rights, safety, and privacy of those patients taking part. The rules also make sure the studies are conducted ethically and within approved medical standards.
Frequently asked questions
This clinical trial aims to see whether the investigational trial drug (Lu AF82422) is effective and safe in slowing the disease progression in people living with multiple system atrophy (MSA).
Approximately 360 people are expected to take part in the MASCOT Trial
There is no cost to participate in the MASCOT Trial. If you are eligible and decide to participate you will receive:
- The investigational trial drug (or placebo)
- Close medical care and follow-up throughout the trial
- Reimbursement for reasonable, trial-related travel and meal expenses
The caregiver can explore participation in this trial on behalf of the person they care for and may complete the Pre-Screening Questionnaire.
During the clinical trial, you may receive the medication that is being studied or you may receive a placebo
A placebo looks like the investigational trial drug being tested, but it doesn’t have any active ingredients. In placebo-controlled research, one group is given the inactive treatment, while another group is given the active treatment. This is the ideal way to find out if the treatment being tested works better than receiving no treatment at all.
During the MASCOT Trial, you will have various tests and assessments to monitor your health and quality of life. These include physical and neurological examinations, vital signs, blood and urine samples for testing, an electrocardiogram, imaging tests (MRI), a lumbar puncture (or “spinal tap”), and completing questionnaires.
Caregiver participation in the trial is required and involves completing a questionnaire periodically throughout the trial.
Participation in any clinical trial is completely voluntary. Your decision to participate—or not participate—in this clinical trial will have no effect on the usual medical care that you receive now or in the future. If you are eligible and choose to participate in the trial, you may leave the clinical trial at any time, and for any reason.
All trial participants will be reimbursed for reasonable, trial-related travel and meal expenses. For more information, please speak to a member of the trial team during your trial visits.
You will first be asked some general questions (here) that help us determine whether you meet the basic criteria to participate in the trial. If you do meet these criteria, you will be contacted by a trial centre to come in for a trial visit in person. At that visit, you’ll be screened to see if you fit the specific eligibility qualifications for the trial.
There are many reasons to participate in clinical research. For starters, it may allow participants to play a more proactive role in their own health by possibly receiving a new investigational drug for an ongoing disease or condition. Participants may also play an important part in bringing much needed drugs to market, benefitting thousands of people who also have the disease or condition. In many cases, this can be life changing. In addition to benefitting those with the disease, participants may be reimbursed for reasonable, trial-related travel and meal expenses.
Participants like you really help make a difference. See if you may be eligible for this research trial.
Every clinical trial must be reviewed, and is continually monitored, by a regulatory review committee to ensure the risks are as low as possible and are worth any potential benefits to the trial participant. As a volunteer, you have the right to discontinue your participation and leave the trial at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
