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

NCT ID: NCT05357677

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2023-01-18

Brief 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.

Conditions

Postherpetic Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SR419-Placebo sequence

30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks

Group Type: EXPERIMENTAL

SR419

Intervention Type: DRUG

SR419 capsule

Placebo-SR419 sequence

placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks

Group Type: EXPERIMENTAL

SR419

Intervention Type: DRUG

SR419 capsule

Interventions

SR419

SR419 capsule

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai SIMR Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fa Bi Fan, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Yong Cui, MD

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

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

Nanyang First People's Hospital

Nanyang, , China

Huazhong University of Science and Technology Union Shenzhen Hospital

Shenzhen, , China

The Second Hospital of Tianjin Medical University

Tianjin, , China

Countries

Australia; China

Other Identifiers

SR419-202

Identifier Type: -

Identifier Source: org_study_id