Skip to main content
OpenTrials
Completed

NCT Number: NCT05357677

To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)

This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

PARC Clinical Research, Royal Adelaide Hospital, Adelaide, Australia

Loading trial locations.

About this study

The study will evaluate the efficacy and safety of SR419 in PHN patients. Each subject will participate in the study for up to approximately 14 weeks. This includes a screening period, drug treatment period, and post-treatment safety follow-up period. This is a crossover design study, in which subjects will be administered with SR419 and placebo according to their randomized sequence, that is, eligible subjects will be randomized in a 1:1 ratio to 1 of 2 double-blind treatment sequences: 30 mg of SR419 administered TID followed by placebo administered TID or placebo administered TID followed by 30 mg of SR419 administered TID.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult male or female over 18 years old;
  • Having neuropathic pain of postherpetic neuralgia (PHN) that persists for >3 months after the herpes zoster rash is healed, with the pain area of a continuous area of affected rash.
  • DN4 score is ≥4 at Screening;
  • Average PI-NRS score of PHN-associated neuropathic pain over the last 24 hours at Screening is ≥4 and ≤9;
  • Female subjects must be non-pregnant and non-lactating;

Exclusion criteria

  • Other pains that cannot be clearly differentiated from PHN and may interfere with PHN assessment;
  • Circumstances that may affect pain assessment as determined by the investigator, such as skin disorders in the affected skin area that may affect sensation;
  • Active herpes zoster infection at screening;
  • Serious acute or chronic medical condition that, as assessed by the investigator, could increase the risks in subjects for participating in the trial or taking the study drug, or interfere with the study results;
  • Previous administration of other study drugs within 30 days or 5 half-lives before the study intervention used in this study (whichever is longer).

Treatment and study plan

SR419

Drug

SR419 capsule

Primary outcomes

  1. Daily Average Pain Score (DAPS)

    Time frame: up to Day 64

    To assess the difference between the two treatment periods in the weekly average of Daily Average Pain Score (DAPS) at the last week. The pain intensity numerical rating scale (PI-NRS) consists of an 11-point numeric scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants described their pain during the past 24 hours by choosing the appropriate number between 0 and 10.

Secondary outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: up to Day 64

    To assess the proportion of subjects who rate their pain as "much improved" or "very much improved" on the Patient Global Impression of Change (PGIC) at the end of each treatment period.

  2. Daily Sleep Interference Score

    Time frame: up to Day 64

    To assess the within-subject difference between the two treatment periods in the weekly average of daily sleep interference scores at the last week. Pain-related sleep interference score was assessed on Daily Sleep Interference Scale (DSIS) which is an 11-point numerical rating scale ranging from 0 (did not interfere with sleep) to 10 (completely interfered [unable to sleep due to pain]). Participants were to describe how their pain had interfered with their sleep during the past 24 hours by choosing the appropriate number between 0 and 10.

  3. Adverse events

    Time frame: up to Day 70

    To collect the adverse events during the study

Other outcomes

  1. Plasma concentration of SR419

    Time frame: on Day 15 and Day 36

    To measure the plasma concentration of SR419 after dosing

Sponsors and collaborators

Lead sponsor

Shanghai SIMR Biotechnology Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Assess the Efficacy, Safety, and Tolerability of SR419 in Patients With Postherpetic Neuralgia (PHN)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 3, 2022
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.