AuthorisedTherapeutic exploratory (Phase II)Interventional

A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of the Safety, Tolerability, and Efficacy of PN6047 HCl in Peripheral Neuropathic Pain Characterized by Mechanical Allodynia

This research is investigating a new medication called PN6047 HCl for a type of nerve pain where normally harmless touches feel painful. This condition is known as mechanical allodynia. The study is in its early stages (Phase II) and focuses on understanding if the medicine is safe to use and whether people can tolerate it well. Researchers will also be looking to see if it helps to reduce the sensation of pain from light touch. Participants will receive either the study medicine or a dummy pill (placebo) at different times, without knowing which they are taking, to fairly compare the effects. The goal is to find better ways to treat this challenging kind of pain.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pharmnovo AB

Enrolment target

Start

30 Sep 2025

Mechanical allodynia

What is this study about?

This study is looking into a new potential medicine called PN6047 HCl. It's designed for people who experience a specific type of nerve pain where even a gentle touch on their skin causes discomfort. This particular type of pain is known as 'mechanical allodynia'. The main goal of this research is to see if this new medicine is safe for people to take and if they can tolerate it without too many unpleasant side effects. It’s an early-stage study, meaning we’re still learning a lot about how this medicine works.

To make sure the results are fair, the study uses a method where some participants receive the new medicine and others receive a dummy pill (a placebo) at different times during the study. Neither you nor your doctor will know whether you are taking the actual medicine or the placebo at any given time. This helps researchers accurately see if any changes are due to the medicine itself and not just the expectation of feeling better.

Throughout the study, doctors and nurses will closely monitor your health. They will check things like your blood tests, heart rhythm (using an ECG), blood pressure, and conduct physical examinations. They will also talk to you about any side effects you might experience. This careful monitoring is crucial to ensure your safety and to understand how well the medicine works in relieving your pain over time.

Key takeaways

The study is for a new medicine for nerve pain from light touch (mechanical allodynia).
It aims to check the medicine's safety, how well it's tolerated, and if it reduces pain.
Participants will receive either the study medicine or a dummy pill at different times.
Your health will be closely monitored throughout the study with regular checks.
It's a Phase II study, meaning it's an early look at this potential new treatment.
You can stop participating at any time.

Who may be eligible?

To take part in this study, you must be at least 18 years old; there's no upper age limit. The study is open to both men and women.

Crucially, you need to be experiencing a specific type of nerve pain where a light touch causes discomfort, especially if you also have this condition called mechanical allodynia.

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 experience nerve pain where a light touch causes discomfort?
Are you able to attend regular clinic visits?
Are you willing to take study medication as directed?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given either the study medicine (PN6047 HCl) or a dummy pill (placebo) at different times. Neither you nor your study doctor will know which you are taking at any given moment. You will take the medicine twice a day. During your time in the study, you'll have several visits to the clinic. At these visits, doctors and nurses will do various checks to monitor your health and how the medicine is affecting you. This includes blood tests, checking your heart with an ECG, measuring your blood pressure and pulse, and doing a full physical and nerve examination. You'll also be asked to describe your pain levels and any side effects you experience. The full duration of your participation will involve taking the medicine for specific periods and regular follow-up appointments.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from this study, but your participation could help researchers learn more about treating nerve pain, which could help others in the future. As with any medicine, there's a chance you might experience side effects from the study drug. These will be monitored closely by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is 'mechanical allodynia'?

It's a type of pain where a light touch or something that shouldn't normally hurt, like clothing or a gentle brush, feels painful. It's often due to nerve damage.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know if you are receiving the active medicine or the dummy pill (placebo). This helps make the study fair and scientific.

What is a 'placebo'?

A placebo is an inactive dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It's used to compare against the real medicine.

What is a 'Phase II' study?

Phase II means it's an early-stage study designed to see if the medicine is safe, what dose might be right, and if it shows promise in treating the condition.

Will I have to pay to join the study?

No, you should not have to pay to participate in a clinical trial. All study-related assessments and the study medicine will be provided free of charge.