Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of pain after intra-articular botulinum toxin injections in carpometacarpal osteoarthritis of the thumb

This study is researching a new way to help people who have pain from arthritis at the base of their thumb, a common place for osteoarthritis. The treatment being tested is an injection of a medicine called NT 201, which is a type of botulinum toxin. Doctors want to find out if this injection can reduce pain more effectively than a placebo, which is an inactive substance that looks just like the real medicine but has no treatment effect. Participants will receive an injection and then their pain will be carefully measured using a simple scale from 0 (no pain) to 10 (worst pain imaginable) at the start and again three months later. This is an early stage study, called a Phase II trial, focused on exploring if the treatment works and is safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Universitaire De Nice

Enrolment target

Start

18 Oct 2024

Osteoarthritis of the first carpometacarpal joint

What is this study about?

This research study is looking into a health problem called osteoarthritis, specifically when it affects the base of your thumb. This condition, often simply called thumb arthritis, can cause pain and stiffness, making everyday tasks difficult. Researchers are exploring if a special injection, called NT 201, which contains a carefully measured amount of botulinum toxin, could help manage this pain.

The main goal of the study is to see if this NT 201 injection can make a real difference to people's pain levels. To do this, some people will receive the actual NT 201 injection, while others will get a placebo. A placebo is like a dummy injection; it looks exactly the same but doesn't contain any active medicine. This helps researchers understand if any improvements are genuinely due to the NT 201 or if they happen for other reasons.

The study will carefully compare the pain levels of participants before and three months after their injection. They will use a simple pain scale, where you rate your pain from 0 to 10. By comparing these scores, the research team hopes to learn if NT 201 is a promising new way to help people with thumb arthritis feel more comfortable.

Key takeaways

This study explores a potential new injection treatment (NT 201) for thumb arthritis pain.
It's a Phase II study, meaning researchers are checking if the treatment works and is safe.
Pain will be measured using a simple 0-10 scale before and 3 months after injection.
Some participants will receive the active treatment, while others will get a placebo (dummy injection).
Adults aged 18 and over with thumb joint arthritis can be considered.
You can stop participating at any time without affecting your normal healthcare.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged at least 18 years old. There is no upper age limit, meaning older adults can also participate.

This study is open to both men and women. The most important requirement is that you have osteoarthritis specifically affecting the first carpometacarpal joint, which is the joint at the base of your thumb.

The research team will have specific medical criteria to make sure the study is right for you and that accurate results can be gathered. These criteria might include details about your thumb arthritis, any other health conditions you have, and medicines you are currently taking.

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 arthritis at the base of your thumb?
Are you able to attend follow-up appointments?
Are you generally in good health, apart from your thumb arthritis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if the study is suitable for you. If you qualify, you would then receive an injection at the base of your thumb. This injection will either contain the study medicine (NT 201) or a placebo, and neither you nor your study doctor will know which you received until the study is over.

After the injection, you would have follow-up appointments, including one specifically at three months. During these visits, the research team will ask you questions about your pain using a simple scale and might perform some gentle checks. The total duration of your involvement in the study is expected to be a few months, mainly focusing on the period up to three months after the injection.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as receiving a new treatment that might help with your thumb pain, and contributing to medical knowledge that could help others in the future. However, there are also potential risks, including side effects from the injection, which could be pain, swelling, or bruising at the injection site. As some participants will receive a placebo, there's a chance you might not receive the active treatment. 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 'Phase II' in a study?

Phase II means this is an early stage study looking into whether the treatment works and is safe. It often involves a smaller group of people than later studies.

What is botulinum toxin?

Botulinum toxin is a substance that can relax muscles. It's used in very small, controlled amounts in medicine for various conditions, including some types of pain.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers see if the actual drug has a real effect.

How will my pain be measured?

Your pain will be measured using a simple scale from 0 to 10. You'll rate your pain, where 0 is no pain and 10 is the worst pain imaginable.

Will I know if I get the real treatment or the placebo?

No, during the study, neither you nor your study doctor will know whether you received the active treatment or the placebo. This helps make the study results fair and accurate.