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 study about?

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.

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).

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.

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.

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.

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
MBAL Sveta Marina EAD	Varna	Bulgaria
Linden Sp. z o.o. sp.k.	Cracow	Poland
Mbal Lyulin EAD	Sofia	Bulgaria
Multiprofile Hospital For Active Treatment Avis Medika OOD	Pleven	Bulgaria
Med Polonia Sp. z o.o.	Poznan	Poland
Diagnostic-consultative center “Aleksandrovska” EOOD	Sofia	Bulgaria
MBAL Dr. Ivan Seliminski – Sliven AD	Sliven	Bulgaria
University Multiprofile Hospital For Active Treatment Eurohospital Plovdiv Ltd.	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD	Pleven	Bulgaria
Ctdb Almnpf Pkjdog Sup z okth	Warsaw	Poland
Zjngmcb Mmjykat Cnmhew Srp z olfp	Lublin	Poland
Nczzdmayql Sjg z oynx socuj	Katowice	Poland
Iaeehtfo Zvxafyv Df Bvumwsluswwwlrudk	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	02.07.2025
Poland	Not recruiting	02.07.2025

Trial locations

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.

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.

Trial ID:

2024-518747-38-00

Protocol code:

iN1011-N17201

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?