Active not recruitingPHASE3INTERVENTIONAL

Study to Compare the Efficacy and Safety of NT 201 (Botulinum Toxin) With Placebo for the Treatment of Lower Limb Spasticity Caused by Stroke or Traumatic Brain Injury

This research is investigating a new medication called NT 201, a type of botulinum toxin, for treating muscle stiffness, known as spasticity, in the legs. This stiffness can happen after a stroke or a traumatic brain injury. The main goal is to find out if NT 201 is more effective than a placebo (a dummy treatment) in reducing this spasticity. Participants will be randomly assigned to receive either NT 201 or the placebo, and neither they nor the study team will know who is getting which treatment. Following this initial stage, all participants will receive NT 201 at different doses to further check its safety and how well people tolerate it over several treatment cycles.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merz Pharmaceuticals GmbH

Enrolment target

603

Start

16 Sep 2019

Estimated completion

01 Apr 2027

Lower Limb or Combined Lower Limb and Upper Limb Spasticity Due to Stroke or Traumatic Brain Injury

What is this study about?

This study is designed to test a new medicine, NT 201, which is a type of botulinum toxin. It's for people who have muscle stiffness, called spasticity, in their legs. This stiffness can make everyday tasks difficult and often happens after a stroke or a serious head injury. We want to see if NT 201 can help to reduce this stiffness more effectively than a placebo, which looks like the real medicine but contains no active ingredients.

In the first part of the study, some people will get NT 201, and others will get the placebo. This is decided by chance, like flipping a coin. Neither you nor the people giving you the treatment will know which one you're getting. This helps us to fairly assess if the medicine is truly working. The treatment will be given as a single injection.

After this first stage, everyone in the study will receive NT 201. This is to help us understand more about its safety and if people can tolerate it well over several more treatment cycles. The amount of NT 201 you receive in this later stage might vary depending on whether your spasticity affects just your legs, or both your arms and legs. We hope this research will provide important information about a potential new way to manage spasticity.

Key takeaways

This study is for adults with leg spasticity from stroke or brain injury.
It tests a new medicine, NT 201, against a dummy treatment (placebo).
Participation involves injections and regular check-ups over several cycles.
All participants will receive NT 201 in the second phase of the study.
You will be closely monitored for safety and how you respond to the treatment.

Who may be eligible?

To join this study, you need to be an adult between 18 and 85 years old. You must have muscle stiffness (spasticity) in your lower leg, with or without stiffness in your upper limb on the same side of your body. This spasticity must have been caused by a stroke or a traumatic brain injury. Specifically, your ankle needs to show a certain level of stiffness that makes your foot point down or turn inwards, and your doctor will check this using a standard scale.

There are also some things that would mean you can't join. For example, if you have certain muscle problems that affect your whole body, or if both your legs are paralysed or very stiff. You also can't take part if you've recently had other treatments for spasticity, such as another botulinum toxin injection within the last four months, or certain surgeries or strong anaesthetic blocks in the affected limb. If you're on blood-thinning medication, your blood levels would need to be within a safe range, and your doctor would discuss this with you.

Quick self-check

Are you 18 to 85 years old?
Do you have muscle stiffness (spasticity) in your lower leg due to a stroke or traumatic brain injury?
Has it been at least 4 months since your last botulinum toxin injection?
Do you weigh more than 50 kg (about 7 stone 12 pounds)?
Are you not currently on certain other spasticity treatments (like intrathecal baclofen or certain surgeries)?
Do you not have other widespread muscle-weakening conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first have some checks to make sure you're suitable. During the main part of the study, you'll receive a single injection of either NT 201 or a placebo. You won't know which one you're getting. After this, there will be several follow-up appointments where the study team will check how you're doing and if the treatment is helping your muscle stiffness.

After the first treatment period, you'll enter an 'open-label' stage. This means everyone will receive NT 201 injections, and you (and the study team) will know you are getting the active medicine. The dose might be adjusted depending on your needs. This part of the study involves four to five more treatment cycles, with regular visits to monitor your safety and how well you tolerate the treatment. The total length of your participation will depend on how many cycles you complete, but it will involve regular visits for assessments and injections over an extended period.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from receiving a new treatment that could improve your muscle stiffness, potentially helping with movement and comfort. Even if you receive the placebo initially, you will receive the active treatment later in the study. However, there are also risks, as NT 201 is a medicine, and side effects can occur, although these will be carefully monitored. The study team will explain all known risks to you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (71)

Physical Medicine and Rehabilitation at University of Alabama at Birmingham; Merz investigational site #0010479
Birmingham, United States
University of Arkansas for Medical Sciences, Merz investigational site #0010481
Little Rock, United States
Rancho Research Institute at Rancho Los Amigos National Rehabilitation Center; Merz investigational site #0010184
Downey, United States
New England institute for clinical research; Merz Investigational Site #0010441
Stamford, United States
Nova Clinical Research, Merz investigational site #0010474
Brandenton, United States
Brooks Rehabilitation Clinical Integration and Research, Merz investigational site #0010483
Jacksonville, United States
Sarasota Memorial Health Care System, Rehabilitation Medicine, Merz investigational site #0010478
Sarasota, United States
Neurology Center of New England P.C., Merz investigative site #0010476
Foxborough, United States
Howard A. Rusk Rehabilitation Center; Merz investigational site #0010283
Columbia, United States
Icahn School of Medicine at Mount Sinai, Neurology Department, Merz Investigational Site #0010191
New York, United States
Weill Cornell Medical Center, Department of Rehabilitation Medicine; Merz Investigational Site #0010440
New York, United States
University of Pittsburgh Medical Center, Physical Medicine & Rehabiliation, Merz Investigational Site #0010211
Pittsburgh, United States

+59 more sites — see the official record for the full list.

Common questions

What is spasticity?

Spasticity is when your muscles become very stiff and tight, making it hard to move them. It can happen after a stroke or a head injury.

What is NT 201?

NT 201 is a medicine, a type of botulinum toxin, that is being tested to see if it can relax stiff muscles caused by spasticity.

What is a placebo?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers fairly compare how well the actual medicine works.

Will I know if I'm getting the real medicine or the placebo?

No, during the first part of the study, neither you nor the study team will know. This is called 'double-blind' and ensures the results are unbiased.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any time, for any reason, and it will not affect your medical care.