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

Primary Purpose

Postherpetic Neuralgia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SR419
Sponsored by
Shanghai SIMR Biotechnology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SR419-Placebo sequence

Placebo-SR419 sequence

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Adverse events
To collect the adverse events during the study

Full Information

First Posted
April 24, 2022
Last Updated
March 19, 2023
Sponsor
Shanghai SIMR Biotechnology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05357677
Brief Title
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 13, 2022 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
January 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai SIMR Biotechnology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SR419-Placebo sequence
Arm Type
Experimental
Arm Description
30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks
Arm Title
Placebo-SR419 sequence
Arm Type
Experimental
Arm Description
placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks
Intervention Type
Drug
Intervention Name(s)
SR419
Intervention Description
SR419 capsule
Primary Outcome Measure Information:
Title
Daily Average Pain Score (DAPS)
Description
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.
Time Frame
up to Day 64
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
up to Day 64
Title
Daily Sleep Interference Score
Description
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.
Time Frame
up to Day 64
Title
Adverse events
Description
To collect the adverse events during the study
Time Frame
up to Day 70
Other Pre-specified Outcome Measures:
Title
Plasma concentration of SR419
Description
To measure the plasma concentration of SR419 after dosing
Time Frame
on Day 15 and Day 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fa Bi Fan, MD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong Cui, MD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
PARC Clinical Research, Royal Adelaide Hospital
City
Adelaide
Country
Australia
Facility Name
PARATUS Clinical Research Brisbane
City
Brisbane
Country
Australia
Facility Name
PARATUS Clinical Research Canberra
City
Canberra
Country
Australia
Facility Name
Genesis Research Services
City
Sydney
Country
Australia
Facility Name
PARATUS Clinical Research Western Sydney
City
Sydney
Country
Australia
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Dermatology Hospital of Southern Medical University
City
Guangzhou
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Facility Name
Nanyang First People's Hospital
City
Nanyang
Country
China
Facility Name
Huazhong University of Science and Technology Union Shenzhen Hospital
City
Shenzhen
Country
China
Facility Name
The Second Hospital of Tianjin Medical University
City
Tianjin
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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