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

NCT05357677 | Completed Phase 2

• 1 other identifier: SR419-202
• Study Type: interventional
• Target: 83
• Locations: 2 countries
• Sites: 13

Brief Summary

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

Conditions

Postherpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Global Impression of Change (PGIC)

  up to Day 64

• Daily Sleep Interference Score

  up to Day 64

• Adverse events

  up to Day 70

Other Outcomes (1)

• Plasma concentration of SR419

  on Day 15 and Day 36

Study Arms (2)

SR419-Placebo sequence

EXPERIMENTAL

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

Drug: SR419

Placebo-SR419 sequence

EXPERIMENTAL

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

Drug: SR419

Interventions

SR419 DRUG

SR419 capsule

Placebo-SR419 sequence; SR419-Placebo sequence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (13)

PARC Clinical Research, Royal Adelaide Hospital

Adelaide, Australia

Location

PARATUS Clinical Research Brisbane

Brisbane, Australia

Location

PARATUS Clinical Research Canberra

Canberra, Australia

Location

Genesis Research Services

Sydney, Australia

Location

PARATUS Clinical Research Western Sydney

Sydney, Australia

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Location

Peking University Third Hospital

Beijing, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Nanyang First People's Hospital

Nanyang, China

Location

Huazhong University of Science and Technology Union Shenzhen Hospital

Shenzhen, China

Location

The Second Hospital of Tianjin Medical University

Tianjin, China

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fa Bi Fan, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

• Yong Cui, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 3, 2022
• Study Start: May 13, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 18, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-03

Locations

CN (8); AU (5)