Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and Tolerability of AP707 in Patients with chronic Pain due to Diabetic Polyneuropathy

This research study is for people who have chronic pain due to diabetic polyneuropathy, which is a type of long-lasting nerve pain often linked to diabetes. The study is trying out a new spray called AP707, which is applied under the tongue. Researchers want to see how well it works to reduce pain compared to a 'dummy' spray (placebo) that looks and tastes the same but has no active medicine. They are also checking if it's safe to use. The study is in its final main stage of testing (Phase III) and aims to understand if this new treatment could be a good option for improving the quality of life for people with this condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Cannaxan GmbH, Apurano Pharmaceuticals GmbH

Enrolment target

558

Start

12 Jun 2023

Chronic pain due to diabetic polyneuropathy

What is this study about?

This research study is about finding better ways to help people who suffer from ongoing pain because of their diabetes. This specific type of pain is called diabetic polyneuropathy, which means the nerves are affected by diabetes, causing discomfort.

The study is testing a new treatment called AP707, which is a spray you use under your tongue. The researchers want to find out two main things: first, how well this spray reduces pain compared to a 'dummy' spray (known as a placebo) which contains no active medicine. The dummy spray looks and smells just like the real one, so neither you nor the doctors will know who is getting which. Second, they want to make sure the treatment is safe and doesn't cause too many side effects.

This is a 'Phase III' study, which means it’s one of the final steps before a new medicine might become widely available. Doctors are collecting detailed information on pain levels over many months to see if AP707 could be a helpful new option for managing this difficult type of pain.

Key takeaways

The study is investigating a new spray treatment (AP707) for chronic diabetic nerve pain.
It aims to see if the spray reduces pain and is safe compared to a placebo (dummy spray).
Participation involves regular use of the spray and clinic visits over a year.
Pain levels and overall well-being will be carefully monitored.
Eligible participants are adults aged 18+ with ongoing diabetic polyneuropathy pain.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The main requirement is that you have ongoing pain caused by diabetic polyneuropathy. This means your pain is directly related to your diabetes affecting your nerves.

There might be other health conditions or medications that would prevent you from joining, but the research team will check all of this carefully 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 ongoing pain caused by diabetes affecting your nerves?
Are you able to attend regular clinic appointments for about a year?
Are you willing to use a new spray treatment (or a dummy spray) as instructed?

Answer every question to see your result.

What does participation involve?

If you participate, you'll be given either the new AP707 spray or a dummy spray to use. You'll use this spray regularly throughout the study, which could last for a full year. You will have regular visits to the clinic where doctors will check your general health and ask about your pain levels. This will involve filling out questionnaires about your pain and how you're feeling, including questions about your mood like stress, anxiety, and depression. They will measure your pain using a simple 0-10 scale. The study involves several follow-up appointments over 52 weeks (about a year) to monitor your progress and check for any side effects.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from the new treatment if it helps reduce your pain. However, there's also a chance you could receive the dummy treatment, which won't directly help your pain. There could be side effects from the new spray, and these will be carefully monitored by the study team. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Austria
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Unverified
Germany

Common questions

What is diabetic polyneuropathy?

It's a type of nerve damage caused by diabetes, which can lead to ongoing pain, often in the hands and feet.

What is a 'dummy' spray (placebo)?

It looks and tastes like the real treatment but doesn't contain any active medicine. It helps researchers see if the real medicine has a true effect beyond what people might feel just by taking something new.

How often will I need to visit the clinic?

You'll have several visits over the course of the study, which lasts up to 52 weeks, to track your progress and well-being.

Can I continue taking my current pain medication?

The study will review your current medications, including those for pain like amitriptyline or gabapentin, and advise you based on the study design. Always discuss all your medications with the study team.

What is a Phase III study?

It's a major stage of research where a new treatment is tested on a larger group of people to confirm its effectiveness and safety before it can be considered for wider use.