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ANERATRIGINE MESILATE

Clinical trials of ANERATRIGINE MESILATE are being done to study safety, tolerability, early signs of benefit, and how the body handles the study drug. The trial data here focus on adults with post herpetic neuralgia, a long-lasting nerve pain after shingles.

Table of Contents

Trial overview

This clinical trial studied ANERATRIGINE MESILATE in people with post herpetic neuralgia, a type of long-lasting nerve pain after shingles.[1] The study title says it was designed to evaluate safety, tolerability, preliminary efficacy, and pharmacokinetics of iN1011-N17-02 in this patient group.[1]

Condition and study population

The condition studied was Post herpetic Neuralgia (PHN).[1] The trial data show that the target population was patients with PHN, meaning people living with nerve pain that remains after shingles.[1]

Study design and treatments

This was an interventional study, which means the researchers gave study treatments and compared outcomes between groups.[1] The interventions listed were ANERATRIGINE MESILATE, placebo for iN1011-N17-02, paracetamol, and Doreta.[1] The presence of a placebo group helps show whether changes in pain are likely due to the study treatment rather than chance or expectation.[1]

Main outcome measured

The primary outcome was the mean change from baseline to the last week of treatment, which was Week 4, in the average weekly numeric rating scale (NRS) pain score.[1] In simple terms, the study measured whether pain scores changed over the 4-week treatment period.[1]

What the trial aimed to learn

The brief summary says the study aimed to identify an optimal dose of iN1011-N17-02 based on a preliminary efficacy signal for pain treatment in PHN.[1] A preliminary efficacy signal means an early hint that the treatment may help, but not yet a final proof.[1] The trial also looked at pharmacokinetics, which describes how the body handles the study drug.[1]

Trial status and size

The trial status is Completed and the enrollment was 140 participants.[1] The study phase was Phase 2, which is a stage that often follows early safety work and focuses more on possible benefit while still watching safety closely.[1]

Trial ID Phase Condition studied Status Enrollment
2024-518747-38-00 Phase 2 Post herpetic Neuralgia Completed 140

FAQ

  • What are the ANERATRIGINE MESILATE trials studying? The trial is studying ANERATRIGINE MESILATE in people with post herpetic neuralgia. It looks at safety, tolerability, early pain relief, and pharmacokinetics, which means how the body absorbs and processes the study drug.
  • Who can take part in these trials? The trial data show participation for patients with post herpetic neuralgia. This means people with this type of nerve pain after shingles were the target group.
  • What phase is the ANERATRIGINE MESILATE trial? The trial is a Phase 2 study. Phase 2 studies usually look more closely at whether a treatment may work and continue to check safety.
  • What result was the study mainly measuring? The main result was the change in average weekly pain score from the start of treatment to Week 4. The pain score used was the numeric rating scale, or NRS, which is a simple pain scale.
  • Was this a treatment comparison study? Yes. The study included ANERATRIGINE MESILATE, placebo, paracetamol, and Doreta. This helps compare the study drug with other treatments and with no active drug.

Ongoing Clinical Trials on ANERATRIGINE MESILATE

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

    Not recruiting

    1 1
    Investigated drugs:
    Bulgaria Poland

Glossary

  • Post herpetic neuralgia (PHN): Long-lasting nerve pain that can remain after shingles has healed.
  • Shingles: A painful skin rash caused by reactivation of the chickenpox virus. The trial data use PHN, which is pain that can follow shingles.
  • Phase 2: A mid-stage clinical trial phase that checks early signs of benefit and continues safety testing.
  • Safety: How well a treatment can be used without causing unacceptable problems in the study setting.
  • Tolerability: How well patients can take the study treatment without it being too hard to continue.
  • Efficacy: How well a treatment works. In this trial, it means early pain relief was being checked.
  • Pharmacokinetics: How the body absorbs, moves through, and removes a drug.
  • Placebo: A look-alike treatment with no active study drug, used for comparison.
  • Numeric Rating Scale (NRS): A pain scale where patients rate pain with numbers. It helps measure pain changes over time.
  • Baseline: The starting point before treatment begins.
  • Week 4: The end of the main treatment period used in this trial to measure the primary outcome.

References

  1. https://clinicaltrials.gov/study/2024-518747-38-00