Status:
COMPLETED
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
Lead Sponsor:
Shanghai SIMR Biotechnology Co., Ltd.
Conditions:
Postherpetic Neuralgia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT05357677
Start Date
May 13 2022
End Date
January 18 2023
Last Update
January 5 2024
Active Locations (13)
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1
PARC Clinical Research, Royal Adelaide Hospital
Adelaide, Australia
2
PARATUS Clinical Research Brisbane
Brisbane, Australia
3
PARATUS Clinical Research Canberra
Canberra, Australia
4
Genesis Research Services
Sydney, Australia