Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A 2-part, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Oral Difelikefalin for Moderate-to-Severe Pruritus in Adult Subjects with Notalgia Paresthetica

This research study is looking into a new oral medicine called Difelikefalin. It's for adults who experience bothersome itching from a skin condition called notalgia paresthetica. This condition can cause moderate to severe itching, and sometimes burning or tingling sensations. The study has two main parts, a Phase II and a Phase III, which are happening at the same time. Participants will receive either the new medicine or a placebo (a dummy pill that looks like the medicine but has no active ingredients). The main goal is to find out if Difelikefalin can significantly reduce the itching compared to the placebo, how it affects other symptoms like burning and tingling, and if it's safe for people to take. Researchers will check participants' itch levels, how their skin looks, and any side effects throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Cara Therapeutics Inc.

Enrolment target

193

Start

05 Oct 2023

Moderate-to-Severe pruritus in adult subjects with notalgia paresthetica

What is this study about?

This study is designed for adults who have a skin condition called notalgia paresthetica, which causes moderate to severe itching. People with this condition often experience itchy patches, usually on their back, and sometimes also feel a burning or tingling sensation. The study is testing a new oral medicine, meaning it's taken by mouth, called Difelikefalin.

The main purpose of this research is to see how well Difelikefalin works to relieve the intense itching caused by notalgia paresthetica. Researchers will compare the effects of this new medicine against a 'placebo', which is a pill that looks exactly like the study medicine but contains no active ingredients. This helps them understand if any improvements are truly due to the medicine or just a placebo effect.

They also want to learn if the medicine can help with other symptoms like burning, tingling, and changes in skin colour. An important part of any new medicine study is to also check its safety and see if there are any side effects. This information will help doctors decide if Difelikefalin could be a helpful treatment option for people with notalgia paresthetica in the future.

Key takeaways

Tests a new oral medicine (Difelikefalin) for severe itching from notalgia paresthetica.
Compares the new medicine with a dummy pill (placebo).
Aims to reduce itching, burning, and tingling.
Studies also look at how safe the medicine is.
Participation helps future patients with notalgia paresthetica.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with notalgia paresthetica and are experiencing itching that is considered moderate to severe. Both men and women are welcome to participate.

To join, you would need to meet certain health criteria that the study doctors will check carefully. These criteria are in place to make sure the study gathers accurate information and that it is safe for all participants.

There might be other reasons why someone can't join, for example, if they are taking certain other medications or have other health conditions. The study team will review all specific requirements with you.

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 a diagnosis of notalgia paresthetica?
Is your itching related to this condition moderate to severe?
Are you willing to take an oral medication as part of the study?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the new medicine, Difelikefalin, or a placebo pill, but neither you nor the study team will know which you are receiving (this is called 'double-blind'). You'll take the assigned medication regularly as instructed.

Your involvement will include regular visits to the clinic where doctors and nurses will monitor your symptoms. They will ask you about your daily itch, burning, and tingling sensations, usually on a scale. They will also look at your skin, particularly any areas with changed colour.

These checks will happen at specific times, including shortly after starting the treatment (on Day 2), and then at Weeks 1, 2, 4, and 8. After the treatment period ends, there will be a follow-up period to monitor any side effects. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as receiving a new treatment that might improve your itching and other symptoms related to notalgia paresthetica. You would also be contributing valuable information that could help others with the same condition in the future. However, there's no guarantee that you will receive the active medicine or that you will personally benefit. As with any medicine, there's always a risk of side effects, which the study team will monitor closely. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
Germany
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Unverified
Poland

Common questions

What is notalgia paresthetica?

It's a common skin condition that typically causes bothersome itching, usually on the back, and sometimes burning or tingling sensations.

What is Difelikefalin?

It's the new medicine being tested in this study to see if it can help reduce itching in people with notalgia paresthetica.

What is a placebo?

A placebo is a 'dummy pill' that looks identical to the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine.

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

No, this is a 'double-blind' study, meaning neither you nor the study doctors will know if you're taking Difelikefalin or the placebo until after the study is complete.

What does 'Phase II and Phase III (Integrated)' mean?

It means the study is combining two important stages of drug testing. Phase II checks if the medicine works well and is safe, and Phase III confirms these findings in a larger group of people before it can be approved.