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

Postherpetic Neuralgia Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05357677
• Other study ID #: SR419-202
• Status: Completed
• Phase: Phase 2
• Start date: May 13, 2022
• Est. completion date: January 18, 2023

Study information

• Verified date: March 2023
• Source: Shanghai SIMR Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: January 18, 2023
• Est. primary completion date: January 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• SR419
SR419 capsule

Locations

Country	Name	City	State
Australia	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
China	China-Japan Friendship Hospital	Beijing	Beijing
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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai SIMR Biotechnology Co., Ltd.

Countries where clinical trial is conducted

Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma concentration of SR419	To measure the plasma concentration of SR419 after dosing	on Day 15 and Day 36
Primary	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	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
Secondary	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
Secondary	Adverse events	To collect the adverse events during the study	up to Day 70