Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Efficacy and Tolerability of AP707 in Patients with Chronic Back Pain

This study, called AP707, is a large research project (Phase III) investigating a new cannabis-based medicine for people suffering from chronic back pain. Doctors are comparing AP707 to a 'dummy' treatment (placebo) to see if it's better at reducing pain levels over time. They'll measure pain using a simple 0-10 scale and watch for changes over 14, 26, and 52 weeks. The study also looks at how the medicine affects daily life, mood, and any side effects. The aim is to find out if AP707 could be a helpful new option for managing long-term back pain.

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 back pain

What is this study about?

If you experience ongoing (chronic) back pain, this study might be of interest. It's looking into a new medicine called AP707, which contains cannabis and is given as a spray under the tongue. The main goal is to find out if this medicine can help reduce back pain more effectively than a ‘dummy’ spray (placebo) which looks and tastes the same but doesn't contain the active ingredient. This is a very important type of study, called a Phase III trial, which means it’s one of the final steps before a new medicine might become widely available.

Researchers will carefully measure changes in participants' pain levels using a simple scale where 0 means no pain and 10 means the worst pain imaginable. They'll check these levels at different times over a year. They'll also look at how pain affects daily activities, your overall mood, and how well you cope with the treatment. The study is designed to be very thorough, comparing the new medicine directly with a placebo to get a clear picture of its effects.

By taking part, you could contribute to medical knowledge and potentially help others with chronic back pain in the future. The trial aims to provide clear answers about whether AP707 is both effective and safe for long-term use in managing this common and often distressing condition.

Key takeaways

This study is testing a new cannabis-based spray (AP707) for long-term back pain.
It's a Phase III trial, meaning it's a key step to see if the medicine can be approved.
The study compares AP707 to a 'dummy' medicine (placebo) to measure its effectiveness.
Pain will be checked regularly using a simple scale over a year.
It's open to adults aged 18 and over with chronic back pain.
Taking part involves regular clinic visits for assessments.

Who may be eligible?

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

The most important thing is that you have chronic back pain. This means your back pain has been ongoing for a while, and it's what the study is specifically designed to investigate.

There might be other health requirements or medicines you're currently taking that could affect whether you can join, but if you meet these basic age and pain criteria, it's worth discussing with your doctor.

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 (chronic) back pain?
Are you able to attend regular clinic appointments for about a year?
Are you generally in good health apart from your back pain?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine (AP707) or a placebo spray, but neither you nor your doctor will know which one you are receiving. This is a standard way to make sure the results are fair. You'll use the spray under your tongue from a small bottle.

You'll have several visits to the clinic over a period of up to 52 weeks (about a year). During these visits, doctors and nurses will check your pain levels using a simple scale, ask you questions about your back pain and how it's affecting your daily life, and assess your mood. They will also keep track of any side effects you might experience. There will be regular checks at 5, 11, 14, 18, 22, 26, 30, 34, 43, 47, and 52 weeks. You'll be able to stop taking part at any time.

Potential risks and benefits

Potential benefits of joining could include feeling better if the new medicine works for you, and helping to find new treatments for chronic back pain. However, there's also a chance you might receive the placebo and not experience any direct benefit from the study treatment. As with any medicine, there could be side effects or risks, which the study team will explain fully. 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
Germany
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Unverified
Austria

Common questions

What is chronic back pain?

Chronic back pain is pain in your back that has lasted for a long time, usually three months or more.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks, tastes, and smells like the real medicine but doesn't contain the active ingredient. It helps researchers compare the true effects of the new medicine.

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

No, during the study, neither you nor your doctor will know whether you are receiving the active medicine (AP707) or the placebo. This is to ensure fair and unbiased results.

How is AP707 taken?

AP707 is given as a pump spray that should be used under your tongue.

How long will the study last?

The study will last for about 52 weeks, which is roughly one year, with regular check-ups during that time.