Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and Tolerability of AP707 in Patients with chronic pain due to central Neuropathy of any Genesis

This study is investigating a new treatment called AP707, which is a pump spray, for people who experience ongoing pain due to nerve damage. The main goal is to see how much pain reduction people experience after 14 weeks compared to a dummy spray (placebo). Researchers will also look at how pain levels change over longer periods, up to a year, and use questionnaires to understand other aspects of pain and well-being. They want to find out if this new spray is safe and helps to ease this type of pain. Participants will be compared to see if the new spray makes a meaningful difference.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Cannaxan GmbH, Apurano Pharmaceuticals GmbH

Enrolment target

558

Start

05 Apr 2023

Chronic pain due to central Neuropathy of any Genesis

What is this study about?

This study is investigating a new pump spray called AP707 for people living with long-term pain caused by nerve damage. This type of pain can be very difficult to manage, so researchers are always looking for new and better ways to help. The spray contains an active ingredient (cannabis sativa, which is a plant extract known to have pain-relieving properties) and will be compared against a 'dummy' spray that looks and smells the same but doesn't contain the active ingredient. This comparison helps researchers truly understand if the AP707 spray is actually working, or if improvements are due to other factors.

Throughout the study, researchers will closely track how participants' pain levels change over several months, using a simple pain rating scale (from 0 to 10). They'll also use detailed questionnaires to measure other aspects of pain and how it affects people's daily lives and mood. The aim is to find out if the AP707 spray can significantly reduce pain and improve quality of life for people with this condition.

This is a 'Phase III' study, which means it's one of the final steps before a new treatment might become more widely available. It's designed to confirm if the treatment is effective and safe for many people, building on earlier research.

Key takeaways

Tests a new spray (AP707) for long-term nerve pain.
Compares the spray to a dummy spray (placebo).
Study lasts for about one year (52 weeks).
Ages 18 and over, open to men and women.
Aims to see if the spray reduces pain and improves well-being.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The most important requirement is that you must have long-term pain caused by nerve damage. This type of pain is often described as burning, shooting, or tingling. The study is looking for people whose nerve pain started because of various原因, which means the cause doesn't have to be specific.

People already taking certain medications for their pain, such as LAMOTRIGINE, AMITRIPTYLINE, PARACETAMOL, or IMIPRAMINE, may still be able to participate. However, the study will have specific rules about whether you can join, which will be discussed fully by the study team.

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 chronic (long-term) pain caused by nerve damage in your brain or spinal cord?
Are you able to attend regular appointments for up to a year?
Are you comfortable using a spray under your tongue?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new AP707 spray or a dummy spray (placebo) to use under your tongue. You won't know which one you're getting, and neither will the study team, until the end of the study. This helps make the study as fair as possible. The spray comes in a 20 ml bottle and has a brownish-beige colour with a sweet, slightly fruity smell.

You will be asked to attend several visits to the study clinic over a period of 52 weeks (about a year). During these visits, your pain levels will be regularly checked using a simple scale (0-10), and you will likely fill out questionnaires about your pain and overall well-being. The study also involves follow-up appointments and assessments at specific times, including at 14 weeks, 26 weeks, and 52 weeks. The study team will provide all necessary medication and support throughout your participation.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available and extra monitoring of your health by a medical team. However, there are also potential risks, including side effects from the study spray or visits that might be inconvenient. The dummy spray won't have active ingredients but could still have a placebo effect. You have the right 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
Austria
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Unverified
Germany

Common questions

What is 'central neuropathy'?

Central neuropathy means long-term pain that comes from damage to nerves in your brain or spinal cord.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks, tastes, and smells like the real thing but doesn't contain any active medicine. It helps researchers compare whether the new treatment actually works.

How long will I be in the study?

The study will last for about a year (52 weeks), with regular check-ups and assessments during that time.

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

No, you won't know which spray you're taking until the study has finished. This is standard practice in clinical trials.

What does a 'pump spray' mean?

It means the medicine is given as a spray, delivered by a pump, usually under your tongue (sublingually) for quick absorption.