Looking for a potential treatment approach for multiple system atrophy (MSA)?
Consider the TOPAS-MSA Study of the investigational medicinal product, TEV-56286
Find a study center near you.We invite you to take part in a research study for adults who are living with multiple system atrophy.
The TOPAS-MSA Study (Targeting Oligomer Pathology of Alpha-Synuclein) is testing an investigational medicinal product (IMP) “TEV-56286” that may help treat MSA. An IMP is a potential medical treatment that is still being studied in clinical trials.
You may be eligible for the TOPAS-MSA Study if you are:
- At least 30 years of age (male or female)
- Diagnosed with “clinically possible” or “clinically probable” MSA
- Able to walk at least 10 meters (33 feet), with or without cane (not a walker)
- Stable (unchanged) on any MSA symptom treatment regimen for at least 28 days
- Able to swallow the 10 capsules once daily
Other eligibility criteria may apply.
The TOPAS-MSA Study includes:
- Screening: up to 28 days
- Treatment Period: 48 weeks
- Follow-up Period: 4 weeks at the end of the treatment
After screening to determine eligibility for the study, participants will enter the treatment period. During the treatment period, participants will take TEV-56286 or matching placebo capsules by mouth each day. The dose is TEN capsules once daily with enough water to swallow ALL of the capsules. This trial is “blinded,” meaning neither you nor the study doctor will know whether you are taking the TEV-56286 or the placebo.
A placebo looks like the investigational medicinal product being tested, but it doesn’t have any active ingredients. In placebo-controlled research like the TOPAS-MSA Study, one group is given the inactive treatment, while another group is given the active treatment. This is the best way to find out if the treatment being tested works better than receiving no treatment at all.
Qualified participants in the TOPAS-MSA Study will receive all study-related visits, tests, and the investigational medicinal product (if assigned to receive it), as well as close care and monitoring from a dedicated medical team at no cost.
Participants who qualify to take part in the study may also receive reimbursement for study-related expenses, and support with travel to and from the study center.
Find a study center
Please select the study center that is most convenient for you.
Clinical research studies are needed to determine whether an investigational medicinal product (IMP) is safe and effective to treat a particular condition or group of patients.
During these studies, information is collected on the effects of the IMP being taken. Once a clinical research study is completed, regulatory agencies carefully review the information. They then decide whether the IMP should be investigated further.
There are guidelines and regulations that must be followed during clinical research studies to help protect the rights, safety, and privacy of participants. The rules also make sure the studies are conducted ethically and within approved medical standards.
Frequently asked questions
The TOPAS-MSA Study is testing how effective, safe and well tolerated the investigational medicinal product called TEV-56286 is in participants who have multiple system atrophy (MSA).
Approximately 200 people are expected to take part in the TOPAS-MSA Study.
There is no cost to participate in the TOPAS-MSA Study. If you decide to take part, you will receive:
- Study-related care from a team of experienced doctors and nurses throughout the study
- All study-related visits, tests, and the investigational medicinal product (if you are assigned to receive it)
During a clinical study, you’ll receive the investigational medicinal product (IMP) that is being studied. This will be done at scheduled times throughout the study, depending on the IMP. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. In some studies, you may not receive the IMP, but instead receive a placebo. All study volunteers are always closely monitored by clinic staff and the medical team to ensure their safety.
Participation in any clinical study is completely voluntary. Your decision to participate – or not participate – in these clinical studies will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to participate in one of these studies, you may leave the clinical study at any time and for any reason.
Qualified study participants may be reimbursed for study-related travel and expenses, or you may be provided with travel support. For more information, please speak with a member of the study team during your study visits.
There are many reasons to participate in clinical research. One of the reasons is that it allows participants to play a more proactive role in their own health by receiving a new experimental treatment option for an ongoing disease or condition. Participants also play an important part in bringing much needed investigational medicinal products to market, benefitting other people who also have the disease or condition, or people who receive a diagnosis in the future.
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 study participant. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.
Teva Pharmaceutical Industries Ltd. is the sponsor and is responsible for conducting this clinical study.
