In short
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.
Key points
- Clinical trial data for ANERATRIGINE MESILATE focus on post herpetic neuralgia, which is long-lasting nerve pain after shingles. The study is a Phase 2, interventional trial with 140 participants. It was designed to assess safety, tolerability, early efficacy, and pharmacokinetics. The main outcome was the change in average weekly pain score from the start of treatment to Week 4. The trial included comparison groups such as placebo, paracetamol, and Doreta. The study status is completed.
Trial overview
This clinical trial studied ANERATRIGINE MESILATE in people with post herpetic neuralgia, a type of long-lasting nerve pain after shingles. The study title says it was designed to evaluate safety, tolerability, preliminary efficacy, and pharmacokinetics of iN1011-N17-02 in this patient group.
Condition and study population
The condition studied was Post herpetic Neuralgia (PHN). The trial data show that the target population was patients with PHN, meaning people living with nerve pain that remains after shingles.
Study design and treatments
This was an interventional study, which means the researchers gave study treatments and compared outcomes between groups. The interventions listed were ANERATRIGINE MESILATE, placebo for iN1011-N17-02, paracetamol, and Doreta. The presence of a placebo group helps show whether changes in pain are likely due to the study treatment rather than chance or expectation.
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. In simple terms, the study measured whether pain scores changed over the 4-week treatment period.
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. A preliminary efficacy signal means an early hint that the treatment may help, but not yet a final proof. The trial also looked at pharmacokinetics, which describes how the body handles the study drug.
Trial status and size
The trial status is Completed and the enrollment was 140 participants. 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.