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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05357677




Registration number
NCT05357677
Ethics application status
Date submitted
24/04/2022
Date registered
3/05/2022
Date last updated
5/01/2024

Titles & IDs
Public title
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
Scientific 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)
Secondary ID [1] 0 0
SR419-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postherpetic Neuralgia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR419

Experimental: SR419-Placebo sequence - 30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks

Experimental: Placebo-SR419 sequence - placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks


Treatment: Drugs: SR419
SR419 capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Daily Average Pain Score (DAPS)
Timepoint [1] 0 0
up to Day 64
Secondary outcome [1] 0 0
Patient Global Impression of Change (PGIC)
Timepoint [1] 0 0
up to Day 64
Secondary outcome [2] 0 0
Daily Sleep Interference Score
Timepoint [2] 0 0
up to Day 64
Secondary outcome [3] 0 0
Adverse events
Timepoint [3] 0 0
up to Day 70

Eligibility
Key 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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/01/2023
Sample size
Target
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
PARC Clinical Research, Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
PARATUS Clinical Research Brisbane - Brisbane
Recruitment hospital [3] 0 0
PARATUS Clinical Research Canberra - Canberra
Recruitment hospital [4] 0 0
Genesis Research Services - Sydney
Recruitment hospital [5] 0 0
PARATUS Clinical Research Western Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Canberra
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Guangzhou
Country [3] 0 0
China
State/province [3] 0 0
Nanchang
Country [4] 0 0
China
State/province [4] 0 0
Nanyang
Country [5] 0 0
China
State/province [5] 0 0
Shenzhen
Country [6] 0 0
China
State/province [6] 0 0
Tianjin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shanghai SIMR Biotechnology Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover
study to assess the efficacy of SR419 in PHN subjects.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05357677
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Fa Bi Fan, MD
Address 0 0
China-Japan Friendship Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries