Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and Tolerability of AP707 in Patients with chronic Pain due to traumatic or post-operative peripheral Neuropathy

This research study, called AP707, is investigating a new sublingual spray designed to help people with ongoing pain due to nerve damage. This type of pain can happen after an injury or surgery. The study wants to find out if this new spray is effective at reducing pain and if it's well-tolerated, meaning it doesn't cause too many side effects. Researchers will compare it to a placebo, which is a dummy spray that looks and tastes the same but has no active ingredients. The study is for adults aged 18 and older, and it will involve regular check-ups to measure pain levels and overall well-being over a long period.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Cannaxan GmbH, Apurano Pharmaceuticals GmbH

Enrolment target

558

Start

06 Apr 2023

Chronic Pain due to traumatic or post-operative peripheral Neuropathy

What is this study about?

This study is looking into a new treatment called AP707, which is a spray used under the tongue. It's designed for people who suffer from chronic pain, which is pain that lasts a long time, often due to damaged nerves. This nerve damage can happen after an injury or surgery.

The main goal of the study is to see how well this new AP707 spray works to reduce pain, and to check if it's safe to use. To do this, some people will receive the actual AP707 spray, while others will get a 'placebo' spray. A placebo looks, smells, and tastes like the real thing but doesn't contain any active medicine. This helps researchers fairly compare the new treatment.

Throughout the study, researchers will regularly ask participants about their pain levels using a simple scale and will also check how their pain affects their daily life and their mood. The study will last for over a year, carefully tracking changes in pain and overall health.

Key takeaways

Tests a new spray (AP707) for chronic nerve pain.
Compares AP707 to a dummy spray (placebo).
Open to adults (18+) with pain from nerve damage after injury or surgery.
Involves using a spray under the tongue and regular check-ups.
Aims to find out if it reduces pain and is well-tolerated.
Participation lasts approximately one year.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The key requirement is that you must be experiencing ongoing (chronic) pain that has been caused specifically by nerve damage. This nerve damage would typically be a result of a past injury or an operation. If your chronic pain has other causes, this study might not be suitable for you.

There might be other health conditions or medications that would prevent you from taking part, but the research team would discuss these specific details with you to see if you are a good fit for the study.

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 long-lasting pain caused by damaged nerves?
Did this nerve damage happen because of an injury or operation?
Are you able to attend regular clinic visits for about a year?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to use a pump spray under your tongue. You won't know if you're getting the active medicine (AP707) or a dummy spray (placebo). Other common pain medications like paracetamol or certain antidepressants (gabapentin, imipramine, amitriptyline) might also be used alongside the study spray, as determined by the study doctors.

You would have regular check-ups at the study clinic over a period of 52 weeks (about a year). During these visits, doctors and nurses would ask you to rate your pain on a simple scale from 0 to 10. They would also ask questions about how your pain affects your daily life and your mood using questionnaires. These visits happen at specific times, with more frequent checks in the first few months. The total duration of your active participation, including check-ups and using the spray, would be about 52 weeks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a new treatment for your pain that isn't available yet. However, there's also a chance you could receive the placebo and experience no direct benefits from the study spray. As with any medication, AP707 could have side effects, and these would be carefully monitored by the study team. You are free to withdraw from 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
Germany
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Unverified
Austria

Common questions

What is 'chronic pain due to nerve damage'?

This is pain that lasts a long time (chronic), typically more than three to six months, and is caused by damage to your nerves. This damage can occur after an injury or surgery.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks identical to the active study spray but does not contain any medicine. It helps researchers find out if the new medicine really works better than no treatment.

Why will I be asked to use a pain scale?

You will be asked to rate your pain regularly on a scale from 0 to 10. This helps the researchers accurately measure if your pain is improving over time with the treatment.

Can I take my usual pain relief during the study?

The study will look at AP707 alone and combined with some common pain medications like paracetamol and certain antidepressants. The study team will advise you on which medications are allowed.

How long will I be in the study?

Your involvement in the study, including using the spray and attending check-ups, will last for about 52 weeks, which is roughly one year.