Safety and effectiveness study of PN6047 HCl in adults with peripheral neuropathic pain and mechanical allodynia

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What is this study about?

This study focuses on people with peripheral neuropathic pain who experience mechanical allodynia, a condition where normal touch causes pain. The research evaluates a new medication called PN6047 HCl, which is taken as a capsule by mouth. The study tests this medication against a placebo to determine if it is safe and effective for treating this type of nerve pain.

The study uses a design where participants receive both the study medication and placebo at different times during the trial. Each person will take either PN6047 HCl capsules or matching placebo capsules for a specified period, and then switch to the other treatment. The maximum daily dose of the study medication is 300 mg, and treatment can last up to 20 days.

Throughout the study, participants will need to rate their pain levels and report how touch affects their pain. The research team will monitor the safety of the treatment by performing various health checks, including blood tests and heart measurements. Participants will also be asked about any changes in their daily activities, sleep, and mood while taking the study medication.

1 Initial trial period

You will start by taking either PN6047 HCl capsules or placebo capsules (inactive substance) orally.

The trial follows a cross-over design, which means you will receive both treatments at different times.

You will need to maintain a pain diary where you will rate your pain twice daily using a scale from 0 to 10.

2 Pain assessments

Your pain will be evaluated in several ways:

Rating your average pain over the last 12 hours

Recording touch-related pain in the painful skin area

Evaluating how pain affects your sleep, daily activities, and mood

Completing a Neuropathic Pain Symptom Inventory

Rating your pain relief experience

3 Blood sampling

Blood samples will be collected on days 7, 20, 35, and 48:

Samples taken before medication and at 30, 60, 90 minutes, and 4 hours after dose

On day 29, only one sample before taking medication will be collected

4 Safety monitoring

Throughout the trial, several safety checks will be performed:

Laboratory tests to monitor your health

Vital signs measurements

Physical examinations including neurological checks

Electrocardiogram (ECG) to monitor heart activity

Any side effects will be recorded and evaluated

5 Rescue medication

Paracetamol will be available as rescue medication if needed

The amount of rescue medication used will be monitored and recorded

Who Can Join the Study?

You must provide informed consent before any trial procedures begin
You must be able to swallow a size 0 capsule
You must be between 18 and 70 years old
Your Body Mass Index (BMI) must be between 18.5 and 35.0
You must have been diagnosed with neuropathic pain (nerve pain) that is either “probable” or “definite”
Your nerve pain must have lasted for at least 3 months
Your pain must be caused by one of these conditions:
– Diabetic neuropathy (nerve damage from diabetes)
– Post-herpetic neuralgia (pain after shingles)
– Nerve injury from trauma, compression, or surgery
Your usual pain level must be between 4 and 9 on a 0-10 scale
You must have pain when touched (mechanical allodynia) with intensity between 4 and 9 on a 0-10 scale
Women who can become pregnant must use highly effective birth control methods during the study and for 30 days after
Men must either use condoms, practice abstinence, or have had a vasectomy during the study and for 30 days after
You must not donate eggs (women) or sperm (men) during the study and for 3 months after
You must be willing to stop taking certain medications at least 5 days before the study begins
You must be able to follow all study requirements as determined by the study doctor

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of chronic pain conditions other than peripheral neuropathic pain
Current use of strong pain medications (such as opioids)
Significant medical conditions affecting the nervous system
History of substance abuse or addiction
Severe kidney or liver problems
Participation in other clinical trials within the past 30 days
Known allergies to the study medication or similar compounds
Uncontrolled high blood pressure or heart conditions
Mental health conditions that could interfere with pain assessment
Use of certain medications that might interact with the study drug
Inability to follow study procedures or attend scheduled visits
History of seizures or epilepsy
Severe skin conditions in areas where pain measurements will be taken

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hospital Del Mar	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.02.2026

Trial locations

PN6047 HCl is an investigational medication being studied for treating peripheral neuropathic pain. This medication is specifically being tested in people who experience pain when their skin is touched lightly, a condition known as mechanical allodynia. The medication is being evaluated to determine if it is safe for patients to use and how well patients can tolerate it.

Mechanical allodynia – A neurological condition where normal, light touch or pressure triggers pain sensations that wouldn’t typically be painful. It occurs when the nervous system becomes oversensitive, causing non-painful stimuli like clothing touching the skin or light pressure to produce pain. The condition commonly develops as part of peripheral neuropathic pain, where nerve damage or dysfunction leads to abnormal pain processing. Normal activities like wearing clothes, being touched, or exposure to mild temperature changes can trigger pain responses. The affected areas of skin become extremely sensitive, and even gentle contact can cause significant discomfort.

Peripheral neuropathic pain – A type of chronic pain caused by damage or disease affecting the peripheral nervous system. The condition results from injury or malfunction of the nerves that carry signals between the central nervous system and the rest of the body. It typically causes burning, tingling, or shooting pain sensations in affected areas. The pain can be constant or occur intermittently, and may be accompanied by numbness or increased sensitivity to touch.

Trial ID:

2024-517304-12-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Safety and effectiveness study of PN6047 HCl in adults with peripheral neuropathic pain and mechanical allodynia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?