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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of NMD670 over 21 days in Ambulatory Adult Patients with Charcot-Marie-Tooth Disease Type 1 and Type 2

This clinical trial is looking into a new medicine called NMD670 for adults who have Charcot-Marie-Tooth disease, specifically types 1 and 2. The main goal is to find out if NMD670 can help people walk further over a short period of 21 days, compared to a placebo (a dummy pill with no active medicine). Researchers also want to make sure the medicine is safe and that people can tolerate it well. Participants will be adults who are able to walk. This is an early stage study to understand if the medicine shows promise before larger studies are done.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
NMD Pharma A/S
Enrolment target
52
Start
11 Jul 2024

What is this study about?

This study is a clinical trial, which means it's a careful way to test new treatments. The treatment being tested is a medicine called NMD670. It's for adults who have a condition called Charcot-Marie-Tooth disease (CMT), specifically types 1 and 2. CMT is a group of inherited conditions that affect the nerves, leading to muscle weakness and problems with feeling in the arms and legs. There isn't a cure for CMT yet, so researchers are always looking for new ways to help manage the condition.

The study aims to see if NMD670 can help people with CMT walk better. To do this, some participants will receive NMD670, and others will receive a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers figure out if any changes are due to the medicine itself or other factors. Both the participants and the study team won't know who is getting which treatment until the study is over – this is called 'double-blind'.

This is a 'Phase 2a' study, which means it's an early stage of testing. The main thing they'll be measuring is how much further people can walk in a 6-minute walking test, comparing those who took NMD670 to those who took the placebo. They'll also be carefully checking for any side effects to make sure the medicine is safe and tolerated well over the 21 days of treatment. Studying NMD670 is important because it could potentially offer a new way to help people with CMT manage their symptoms and improve their daily lives.

Key takeaways

  • This study tests a new medicine (NMD670) for CMT types 1 and 2.
  • It aims to see if NMD670 helps people walk further and if it's safe.
  • Participants will receive either the medicine or a dummy pill (placebo).
  • The study lasts for 21 days of treatment, plus follow-up.
  • It's an early-stage study for adults who can walk.
  • You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older, and be able to walk on your own.

The study is open to both men and women.

Specific medical details about your Charcot-Marie-Tooth disease (types 1 or 2) will be checked by the study doctor to make sure you're a good fit for this particular trial. This includes ensuring your overall health allows for safe participation.

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.

  1. Are you 18 years old or older?
  2. Do you have Charcot-Marie-Tooth disease type 1 or type 2?
  3. Are you able to walk on your own?
  4. Are you able to commit to 21 days of treatment and follow-up visits?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine (NMD670) or a placebo, which is a dummy pill. You wouldn't know which one you're getting. The main treatment period is 21 days. During this time, you would have regular visits to the clinic for various assessments. These might include physical exams, blood tests, and the 6-minute walking test to see how far you can walk in that time. The total duration of your involvement, including follow-up visits after the medicine period, might extend a little beyond the 21 days.

Potential risks and benefits

Taking part in a clinical trial might offer the potential benefit of trying a new medicine that could help your condition, which is not yet available to everyone. However, there's no guarantee you'll receive the active medicine or that it will help you. There could be risks, including potential side effects from the medicine, some of which may be unknown. All procedures in the study carry some level of risk, even if small. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Spain
  • Unverified
    Belgium
  • Unverified
    France
  • Unverified
    Denmark

Common questions

What is Charcot-Marie-Tooth disease?

Charcot-Marie-Tooth (CMT) disease is a group of inherited conditions that affect the nerves, leading to muscle weakness and problems with sensation, mainly in the feet, legs, hands, and arms.

What is a 'Phase 2a' study?

A Phase 2a study is an early stage of research. It's designed to see if a new medicine works and if it's safe for people, usually in a small group of patients, before larger studies are done.

What is a 'placebo'?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medicine but doesn't contain any active ingredients. It helps researchers understand if the real medicine is actually working.

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

No, this is a 'double-blind' study, meaning neither you nor the study team will know who is receiving the active medicine and who is receiving the placebo until the study is finished.

What is the 6-minute walking test?

The 6-minute walking test is a simple assessment where you walk as far as you can in 6 minutes. It's used to measure your walking ability and any changes over time.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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