Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Multicentre, Interventional, Post-marketing, Randomised, Double-blind, Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport®) in Comparison with OnabotulinumtoxinA (Botox®) when Treating Adults with Upper Limb Spasticity

This research is looking at two widely used injectable medicines, Dysport and Botox, to see which is better and safer for adults who have stiff muscles in their arms. This stiffness, called upper limb spasticity, can happen after a stroke or other conditions. The study is particularly interested in any side effects and how long the positive effects of the treatment last. It will check how much the muscles relax, how much a person's movement and pain improve, and how their quality of life changes. This is a "real-world" study, meaning it looks at how well these medicines work in typical day-to-day medical care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Ipsen Pharma

Enrolment target

Start

21 Mar 2024

Upper limb spasticity (ULS) of any aetiology (in US and France) or post- stroke ULS (in Canada)

What is this study about?

Imagine your arm muscles are constantly tight and stiff, making it hard to move or do everyday things. This condition is called upper limb spasticity, and it can happen for various reasons, for instance, after a stroke. There are medicines that can help relax these muscles, and two common ones are Dysport and Botox. This study aims to compare these two medicines directly.

The main goal of this research is to understand how safe Dysport and Botox are when used to treat stiff arm muscles. Researchers will carefully track any side effects people experience. They also want to see how well each medicine works, for example, how much it reduces muscle stiffness, how it helps with arm movement, and if it lessens any pain people might have. This comparison will help doctors and patients make informed decisions about which treatment might be best.

This is a special type of study called a 'crossover' study, meaning that participants will try both medicines at different times. This allows researchers to see how each individual responds to both treatments, making the results very clear. Because this is a 'real-world' study (Phase IV), it helps us understand the effects of these medicines in standard medical practice, building on what we already know from earlier research.

Key takeaways

Compares two common muscle-relaxing injections: Dysport and Botox.
Aims to understand their safety and how well they reduce arm stiffness.
Designed for adults with stiff arm muscles (upper limb spasticity).
Participants will try both medicines, allowing for direct comparison.
Looks at muscle stiffness, movement, pain, and quality of life.
Participation involves injections and regular follow-up visits.

Who may be eligible?

This study is looking for adult volunteers who have stiff muscles in their arms, a condition known as upper limb spasticity. This stiffness could be due to a variety of causes in the US and France, but in Canada, it specifically needs to be related to having had a stroke.

To be eligible, you must be at least 18 years old. There's no upper age limit, meaning older adults are very welcome to participate. The study is open to both men and women.

The important thing is that your doctor thinks your stiff arm muscles could benefit from treatment with Dysport or Botox, and that you are generally healthy enough to take part in a study of this kind.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have stiff or tight muscles in your arm (upper limb spasticity)?
If you're in Canada, is your arm stiffness due to a stroke?
Are you able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive injections of either Dysport or Botox into your arm muscles to help with stiffness. Because this is a 'crossover' study, you would receive one medicine for a period, and then, after a break, you would switch to receive the other medicine. This allows doctors to compare how each treatment works for you.

You would have several appointments over many weeks. During these visits, doctors would assess your muscle stiffness, your arm movement, any pain you have, and how your daily life is affected. They'll also ask you about any side effects you experience. These check-ups would happen at regular intervals, such as 1, 4, 10, 12 weeks, and then potentially at 16, 20, and 24 weeks after each injection. The total duration of your participation in the study would depend on how many cycles of treatment you receive, as each cycle is followed by careful observation.

Potential risks and benefits

Participating in this study might offer you benefits such as potentially improved muscle stiffness, better arm movement, and reduced pain from either Dysport or Botox. It's important to know that, like all medicines given by injection, there can be potential risks. These might include temporary pain, bruising, or swelling at the injection site, or other side effects related to the medicines themselves. The researchers will closely monitor you for any unwanted effects. 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 usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'upper limb spasticity'?

It's when your arm muscles become very stiff and tight, often after problems like a stroke, making it hard to move them normally.

What are Dysport and Botox?

They are both injectable medicines used to relax muscles that are too stiff. They are common treatments for conditions like spasticity.

Will I get both medicines?

Yes, in this study, you will try both Dysport and Botox at different times to see how each works for you.

What's the main thing the study is looking for?

The study's main goal is to compare the safety and effectiveness of Dysport versus Botox for treating stiff arm muscles, including any side effects.

How long will the study last?

You'll have regular check-ups for several weeks after each injection, potentially over many months, to see how the treatments affect you.