To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
- Registration Number
- NCT05357677
- Lead Sponsor
- Shanghai SIMR Biotechnology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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;
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SR419-Placebo sequence SR419 30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks Placebo-SR419 sequence SR419 placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks
- Primary Outcome Measures
Name Time Method Daily Average Pain Score (DAPS) up to Day 64 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
Name Time Method Daily Sleep Interference Score up to Day 64 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 up to Day 70 To collect the adverse events during the study
Patient Global Impression of Change (PGIC) up to Day 64 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.
Trial Locations
- Locations (13)
PARATUS Clinical Research Brisbane
🇦🇺Brisbane, Australia
Peking University Third Hospital
🇨🇳Beijing, China
Genesis Research Services
🇦🇺Sydney, Australia
PARATUS Clinical Research Western Sydney
🇦🇺Sydney, Australia
The Second Affiliated Hospital of Guangzhou Medical University
🇨🇳Guangzhou, China
Dermatology Hospital of Southern 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
PARATUS Clinical Research Canberra
🇦🇺Canberra, Australia
PARC Clinical Research, Royal Adelaide Hospital
🇦🇺Adelaide, Australia
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China