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Study of aneratrigine mesilate (iN1011-N17-02) to find the best dose for treating pain in adults with post-herpetic neuralgia

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial aims to find the optimal dose of iN1011-N17-02 for treating pain in patients with Post-herpetic Neuralgia, a condition where pain persists for at least 3 months after a herpes zoster rash. The study will test different doses of the investigational medication iN1011-N17-02, which contains the active substance aneratrigine mesilate.

The study will compare iN1011-N17-02 with placebo, and patients may also receive other pain medications including paracetamol and tramadol hydrochloride as needed. The medications will be taken orally in the form of capsules or tablets. The treatment period will last for 4 weeks, during which patients will need to regularly rate their pain levels.

Throughout the study, researchers will monitor how well the medication works in reducing pain. They will also track any side effects and measure how the medication is processed by the body. Patients will complete various questionnaires about their pain experience and how it affects their daily activities and sleep. Blood and urine samples will be collected to understand how the medication moves through the body.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your eligibility for participation will be evaluated based on specific criteria, including age (19-80 years), confirmed diagnosis of post herpetic neuralgia (pain lasting at least 3 months after shingles rash), and pain intensity score.
Basic health measurements will be taken, including weight, height, and calculation of body mass index (BMI must be between 18 and 40).
Step 2
Baseline measurements
You will undergo several examinations including physical check-up, vital signs measurement, heart examination (ECG), and laboratory tests.
Your pain levels will be assessed using various questionnaires and a numeric rating scale.
Step 3
Treatment period
The treatment period will last 4 weeks.
You will receive either iN1011-N17-02 (study medication) or a placebo in oral form.
The medication will be taken twice daily.
During this period, you must discontinue other pain medications except for permitted rescue medication.
Step 4
Monitoring and assessments
Throughout the 4-week period, you will need to record your daily pain intensity.
Regular assessments of your pain will be conducted using various questionnaires.
Blood samples will be collected to measure medication levels in your system.
Your sleep quality and daily activities will be evaluated.
Step 5
Final evaluation
At the end of week 4, final assessments will be performed including physical examination, laboratory tests, and heart examination.
Your overall response to treatment will be evaluated through pain questionnaires and global impression of change scales.
Any side effects or health changes during the study period will be documented.

Who can join the trial?

11 criteria

Age between 19 and 80 years old
Must be willing to provide written informed consent to participate in the study
Must have post herpetic neuralgia (ongoing pain after shingles rash) for at least 3 months and have received treatment for minimum 1 month
Must have a pain score between 4 and 9 on a scale of 0-10 during the week before starting the study
Body weight must be at least 45 kg and body mass index (BMI) must be between 18 and 40
If able to have children, must use effective birth control methods throughout the study and for:
- 30 days after last dose for females
- 90 days after last dose for males
- Must be able to understand study information and attend all required study visits
- If currently taking pain medications:
  - Must be safe to stop taking them (as determined by study doctor)
  - Must be willing to stop all non-study pain medications during the study
  - May only use allowed rescue pain medication

Who cannot join the trial?

15 criteria

Age below 18 years or above 75 years
Pregnant or breastfeeding women
History of allergic reactions to similar medications
Current participation in other clinical trials
Presence of other chronic pain conditions that could interfere with pain assessment
Severe liver or kidney disease (conditions affecting how your body processes medications)
Uncontrolled high blood pressure or heart disease
History of drug or alcohol abuse within the past year
Mental health conditions that could affect the ability to follow study procedures
Use of certain pain medications that cannot be stopped during the trial
Skin conditions in the affected area that could interfere with assessment
Planned surgery or medical procedures during the study period
Inability to follow study procedures or attend scheduled visits
Conditions that weaken the immune system (immunocompromised)
Current active infection or fever

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Diagnostic-consultative center “Aleksandrovska” EOOD
Sofia, Bulgaria
Responsive
Linden Sp. z o.o. sp.k.
Cracow, Poland
Not recruiting
Verified
Med Polonia Sp. z o.o.
Poznan, Poland

Trial locations

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Investigated drugs

iN1011-N17-02 is an investigational medication being studied for treating pain in people who have Post-Herpetic Neuralgia (PHN), a type of nerve pain that occurs after shingles. The medication is being tested to find the best dose that can effectively reduce pain while being safe for patients. This is an experimental drug that is still in early stages of research (Phase 2) and is not yet approved for general use.

What is already known about the treatment

iN1011-N17-02 - An investigational medication currently being studied in Phase 2 clinical trials for the treatment of Post-herpetic Neuralgia (PHN), a type of nerve pain that occurs after shingles infection. The drug is being evaluated for its safety, tolerability, and effectiveness in managing PHN-related pain, with researchers working to determine the optimal dosing regimen. While the specific mechanism of action and form of administration are not detailed in the available trial information, this experimental treatment is being tested through a randomized, double-blind, placebo-controlled study design to ensure reliable scientific results.

Investigated diseases

Post-herpetic Neuralgia – A painful condition that occurs after a shingles (herpes zoster) infection has cleared. It develops when nerve fibers are damaged during the shingles outbreak, causing pain that persists in the affected area long after the rash and blisters have healed. The pain typically occurs in the same location where the shingles rash appeared and may feel like burning, stabbing, or shooting sensations. The affected skin may be very sensitive to touch, temperature changes, and even light breezes. The condition most commonly affects the torso, but can occur anywhere on the body where the shingles rash was present.