A clinical trial to evaluate NT 201 as a treatment for lower limb spasticity caused by stroke or traumatic brain injury (the PATTERN trial)

Clinical trials are scientific experiments in people, led by researchers and doctors. Clinical trials provide valuable information and help us improve healthcare. They can help us understand a condition better and learn how best to treat it and can lead to new treatments being made available. People decide to participate in clinical trials for a variety of reasons. Some wish to contribute to medical research, potentially to help others with the same condition. Others may wish to try a new approach to therapy or want to receive a treatment that might not otherwise be available to them.

All drugs must go through several phases of clinical research before they can be made available to the public. The earliest clinical trial phases that investigational drugs go through look at whether a drug is safe and explore any side effects it might cause. A later phase clinical trial aims to test whether a new treatment is effective and safe. The PATTERN trial is a Phase 3 clinical trial, which is investigating whether the trial treatment, NT 201, is effective and safe in treating lower limb spasticity.

A placebo is a treatment that looks exactly like the trial drug but contains no active ingredients. In clinical trials, researchers often compare an investigational treatment with a placebo. All of the participants receive the same level of quality care, regardless of whether they are assigned to receive the investigational drug or the placebo – the only difference is whether they actually receive the trial drug. This helps researchers better evaluate the true effects of the drug.

Every person who takes part in a clinical research trial is supported by a dedicated team that includes doctors, nurses, and other healthcare professionals. The commitment of each participant and the entire trial team is important to help meet the objectives of the trial. All clinical trials are performed according to strict ethical and governmental guidelines, to ensure that participants’ rights are protected while key trial information is being collected.

Before taking part in any clinical trial, you will be given detailed information about the trial to review. If, after reviewing this information, you agree to take part, you will then be asked to give written informed consent. Then, the trial team can perform a complete eligibility check to confirm whether or not you can take part. If you are interested in learning more about this trial or wish to take part, you can see if you are potentially eligible by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

You are free to leave the trial at any time, and this will not affect your future care in any way. Your doctor will continue to provide care and advise about alternative treatment options.

All medications, both those that are approved and those undergoing clinical trials, may potentially cause side effects. Some of these side effects are known, but there could be others that have not previously been observed. Trial procedures may also involve risks. You will have been informed about all of the known potential side effects of the trial treatment and trial procedures before you decided to take part in this trial. If any further risks are discovered while the trial is ongoing, you will be informed immediately. Please contact your trial doctor if you have any questions about any known or potential side effects. If you do experience any symptoms or discomfort during the trial, you can contact the trial doctor at any time to discuss them. Your trial doctor may give you medications to relieve your symptoms or may decide to stop the trial treatment.

If your condition gets worse after you start the trial, your trial doctor will discuss additional or alternative treatment options with you, if necessary. These options may include continuing with the trial treatment, withdrawing from the trial, switching to a different type of treatment, or taking medication to relieve your symptoms. Your health and well-being are of utmost importance during the trial, and any decisions regarding the trial treatment or any alternative treatments will be made with that in mind.

Due to the extra precautions needed to minimize the spread of COVID-19, your participation and some trial-related assessments may be impacted. For example, you may notice extra safety and hygiene precautions at your clinic, such as social distancing in the waiting room. You must notify your doctor before your trial visit if you have symptoms typical of COVID-19. And, if hospitals or clinics are closed or if local travel restrictions are in place, you may be asked to complete several assessments over the phone instead of at the trial clinic.

Your trial treatment may need to be paused due to pandemic-related reasons. If the pause lasts for more than 20 weeks, you will be asked to undergo a trial re-start assessment to ensure you are still eligible to participate in the trial. If based on these assessments, your doctor decides that you should not receive any further trial treatment, you will leave the trial. Please communicate closely with your doctor if you have any questions and have noticed any potential COVID19related symptoms.

You may or may not receive any benefit from being in the trial. It is possible that you may get better, stay the same, or get worse. If you take part in this trial, other people with lower limb spasticity may be helped by the research.