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)

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

Study Overview

• Status: Completed
• Conditions: Postherpetic Neuralgia
• Intervention / Treatment: Drug: SR419

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • PARC Clinical Research, Royal Adelaide Hospital
  • Brisbane, Australia
    • Paratus Clinical Research Brisbane
  • Canberra, Australia
    • Paratus Clinical Research Canberra
  • Sydney, Australia
    • Genesis Research Services
  • Sydney, Australia
    • Paratus Clinical Research Western Sydney
• China
  • Beijing, China
    • Peking University Third Hospital
  • Guangzhou, China
    • Dermatology Hospital of Southern Medical University
  • Guangzhou, China
    • The Second Affiliated Hospital of Guangzhou Medical University
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Nanyang, China
    • Nanyang First People's Hospital
  • Shenzhen, China
    • Huazhong University of Science and Technology Union Shenzhen Hospital
  • Tianjin, China
    • The Second Hospital Of Tianjin Medical University
  • Beijing
    • Beijing, Beijing, China
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SR419-Placebo sequence; 30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks	Drug: SR419; SR419 capsule
Experimental: Placebo-SR419 sequence; placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks	Drug: SR419; SR419 capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Average Pain Score (DAPS)	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.	up to Day 64

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Change (PGIC)	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.	up to Day 64
Daily Sleep Interference Score	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.	up to Day 64
Adverse events	To collect the adverse events during the study	up to Day 70

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of SR419	To measure the plasma concentration of SR419 after dosing	on Day 15 and Day 36

Collaborators and Investigators

• Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
• Investigators: Principal Investigator: Fa Bi Fan, MD, China-Japan Friendship Hospital; Principal Investigator: Yong Cui, MD, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): January 13, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: April 24, 2022
• First Submitted That Met QC Criteria: May 1, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic
• Other Study ID Numbers: SR419-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No