Clinical trial NCT05357677: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Shanghai SIMR Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Daily Average Pain Score (DAPS)
timeFrame: up to Day 64
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: up to Day 64
measure: Daily Sleep Interference Score
timeFrame: up to Day 64
measure: Adverse events
timeFrame: up to Day 70
Other outcomes:
measure: Plasma concentration of SR419
timeFrame: on Day 15 and Day 36
Locations:
city: Adelaide
country: Australia
facility: PARC Clinical Research, Royal Adelaide Hospital
city: Brisbane
country: Australia
facility: PARATUS Clinical Research Brisbane
city: Canberra
country: Australia
facility: PARATUS Clinical Research Canberra
city: Sydney
country: Australia
facility: Genesis Research Services
city: Sydney
country: Australia
facility: PARATUS Clinical Research Western Sydney
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
city: Guangzhou
country: China
facility: The Second Affiliated Hospital of Guangzhou Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Nanyang
country: China
facility: Nanyang First People's Hospital
city: Shenzhen
country: China
facility: Huazhong University of Science and Technology Union Shenzhen Hospital
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
Study officials:
affiliation: China-Japan Friendship Hospital
name: Fa Bi Fan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: China-Japan Friendship Hospital
name: Yong Cui, MD
role: PRINCIPAL_INVESTIGATOR
References: