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To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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)

NCT05357677•Shanghai SIMR Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adult male or female over 18 years old;
•2. 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.
•3. DN4 score is ≥4 at Screening;
•4. Average PI-NRS score of PHN-associated neuropathic pain over the last 24 hours at Screening is ≥4 and ≤9;
•5. Female subjects must be non-pregnant and non-lactating;

Exclusion Criteria

•1. Other pains that cannot be clearly differentiated from PHN and may interfere with PHN assessment;
•2. Circumstances that may affect pain assessment as determined by the investigator, such as skin disorders in the affected skin area that may affect sensation;
•3. Active herpes zoster infection at screening;
•4. 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;
•5. Previous administration of other study drugs within 30 days or 5 half-lives before the study intervention used in this study (whichever is longer).

Locations (13)

PARC Clinical Research, Royal Adelaide Hospital

Adelaide, Australia

PARATUS Clinical Research Brisbane

Brisbane, Australia

PARATUS Clinical Research Canberra

Canberra, Australia

Genesis Research Services

Sydney, Australia

PARATUS Clinical Research Western Sydney

Sydney, Australia

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, China

Dermatology Hospital of Southern Medical University

Guangzhou, China

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Key Dates

Start Date

May 13, 2022

Primary Completion Date

January 13, 2023

Completion Date

January 18, 2023

Last Updated

January 5, 2024

Enrollment

ACTUAL participants

Conditions

Postherpetic Neuralgia

Interventions

SR419

DRUG

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

NCT07000409

Postherpetic NeuralgiaChronic Pain+3 more

View study

RECRUITINGNA

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

NCT06896994

Postherpetic Neuralgia

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

The Effectiveness of Ultra-Sound Guided Erector Spinae Block With Betamethasone for Management of Truncal Chronic Post Herpetic Neuralgia.

Esketamine Combined Pregabalin and Duloxetine for Postherpetic Neuralgia

Relationship Between Serum Vitamin D Levels and Postherpetic Neuralgia.

Dorsal Root Ganglion Stimulation in Postherpetic Neuropathy

Predictors of Success After Intercostal Nerve Radiofrequency Treatment for Intercostal Neuralgia

Safety and Efficacy Study of KAI-1678 to Treat Pain in Subjects With Postherpetic Neuralgia