Diagnosed with Relapsing Multiple Sclerosis?

Consider joining the ENSURE clinical study

About the ENSURE Study

The ENSURE study is a clinical study of a potential new oral study drug for patients diagnosed with relapsing multiple sclerosis (RMS), a chronic disease affecting the brain and spinal cord. Patients with multiple sclerosis can experience a variety of symptoms, including problems with vision, bladder control, arm or leg movement, sensation or balance. Relapsing MS is characterized by attacks, also called relapses, meaning new or worsening of symptoms, lasting for at least 24 hours before full or partial recovery.

The purpose of the ENSURE study is to investigate how well the oral study drug works and how safe it is in patients with RMS. The study will be conducted at around 100 medical sites worldwide and 1050 patients are planned to take part in this clinical study.

Who Can Participate?

You may be eligible to participate in the ENSURE study if you:
are between 18 and 55 years old
are diagnosed with RMS
have a recent history of active disease, meaning at least 2 relapses in the last 2 years or 1 relapse in the last year.

Short Study Summary

Medical Condition:

Relapsing Multiple Sclerosis (RMS)

Study Duration:

up to 9.5 years

Phase:

This is a phase 3 study, in which the study drug is given to a larger group of patients to investigate how well it works and how safe it is to use for patients with RMS.

What are the Next Steps if I am Interested to Participate in the ENSURE Study?

There are other criteria that need to be fulfilled to be able to take part in the ENSURE study.

If you decide you want to join the ENSURE study and if your study doctor confirms that you could be a good match, you will be asked to visit the study clinic for a screening visit. During this visit, you will be asked to read the study information and sign an informed consent form before any procedures are performed.

Additional tests will be performed to determine if your qualify to participate in the study.

To find out if the study may be suitable for you, please click the button:

STEP 1

Answer some questions about your RMS to ensure that this study is right for you.

STEP 2

A nurse will get in touch with you on the phone to ask some additional questions about your RMS.

STEP 3

You will be contacted by the study clinic to schedule a screening visit.

What Does It Mean to Participate in the ENSURE Study?

The ENSURE study includes 2 separate periods:

about
1.5 years

Main treatment period

During this time, you will be placed in one of two groups: one group will receive the study drug and the other group will receive a placebo. Placebo is a pill that looks like the study drug but does not contain any active ingredients.
There is a 50% chance that you will receive the study drug. Neither you nor your study doctor will know whether you receive the study drug or placebo.
You will take the study drug or placebo by mouth, as a pill, each morning.
You will need to come back to the study site after 4 weeks, and then every 12 weeks to be evaluated for a total of 8 visits.
If your study doctor confirms that your disease or any of your disabilities worsened during this period, you will have a few different options. If you find out that you are in the placebo group, you will have the option to stay in the study and switch to active study drug.

up to
8 years

Extended treatment period

After you complete the main treatment period, your study doctor will determine if you are eligible to participate in the extended treatment period.
During the extended treatment period, all participants will receive active study drug. So, if you choose to participate, you will receive active study drug independently of what study medication you received during the main treatment period.
This part of the study allows more time to see how the study drug may help to improve RMS.

You will need to return to the study site after 4 weeks, and then every 24 weeks for up to 8 years to be evaluated. Your participation is completely voluntary. You can choose to leave at any time without any further explanation and without any impact on your future care.

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For additional information about clinical studies in general please see the FAQ-section

Frequently Asked Questions

What is a clinical study?
Clinical studies explore whether a medicine, treatment, or device is safe and effective for humans.

Clinical studies are scientific studies in which new medicines and treatments are tested to make sure they are safe and effective for people to take and use. They are one of the most important steps in bringing new treatments to patients.

Why is clinical research important?
Clinical research adds to medical knowledge and helps bring new treatments to people with medical conditions. In order to make new treatments available to the public they need be studied in clinical trials.

Clinical trials rely on the participation of volunteers in order to succeed. On average, it can take up to 8 years for a new treatment to reach the public, the major hold-up being how long it takes to complete the clinical trials (often due to shortage of participants).

All new medical treatments and drugs have gone through clinical trials to make sure that they are safe and effective.

Who runs clinical studies?
Clinical studies can be sponsored, or funded, by pharmaceutical companies, academic medical centres, voluntary groups, or health care providers.

Every clinical study is led by a principal investigator, who is often a medical doctor. Clinical studies also have a research team that may include doctors, nurses, social workers, and other health care professionals.

What are the phases of clinical research studies?
Clinical studies are conducted in different phases:

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the effect in various populations and any side effects associated with long-term use.

What does it mean to participate?
Taking part in a clinical trial typically involves taking tests to ensure you are a match for the study. If you qualify, you will visit the clinic regularly to receive the drug or treatment. The study staff will monitor your progress and well-being.

Before taking part in a trial, you are informed about what it means to participate in the study, including how the study is conducted, how you are protected during the study and the risks and benefits of participating. You may choose to end your participation in the study at any time.

You should learn about the risks and benefits of any clinical trial before you agree to take part in a trial. Talk to your doctor about specific trials you’re interested in.