Postherpetic NeuralgiaPhase 2NCT05357677
To Evaluate the Efficacy and Safety of SR419 in Patients With Postherpetic Neuralgia (PHN)
A Phase 2 study testing SR419 in people with Postherpetic Neuralgia, run by Shanghai SIMR Biotechnology Co., Ltd. at 13 sites in 2 countries.
Trial summary
This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postherpetic Neuralgia
- What is being tested?
- SR419
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 13 May 2022to 18 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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).
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
China8 sites
China-Japan Friendship Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing
Dermatology Hospital of Southern Medical University
Guangzhou
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
The First Affiliated Hospital of Nanchang University
Nanchang
Nanyang First People's Hospital
Nanyang
Huazhong University of Science and Technology Union Shenzhen Hospital
Shenzhen
The Second Hospital of Tianjin Medical University
Tianjin
Australia5 sites
PARC Clinical Research, Royal Adelaide Hospital
Adelaide
PARATUS Clinical Research Brisbane
Brisbane
PARATUS Clinical Research Canberra
Canberra
Genesis Research Services
Sydney
PARATUS Clinical Research Western Sydney
Sydney
About this study
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)
This is a Phase II, international multicenter, double-blind, placebo-controlled, crossover study to assess the efficacy of SR419 in PHN subjects.
Read the 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.
- Conditions
- Postherpetic Neuralgia
- Being tested
- SR419
- Medical subject headings
- Neuralgia, Postherpetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR419Drug
SR419 capsule
| Study group | Role | What they receive |
|---|---|---|
| SR419-Placebo sequence | Experimental | 30 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks Receives: Drug: SR419 |
| Placebo-SR419 sequence | Experimental | placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks Receives: Drug: SR419 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to Day 64
Secondary outcomes (3)
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.
Measured: up to Day 64
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.
Measured: up to Day 64
Adverse events
To collect the adverse events during the study
Measured: up to Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start13 May 2022
- Primary completion13 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postherpetic NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fa Bi Fan, MD, Principal investigator, China-Japan Friendship HospitalYong Cui, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357677
- Sponsor's protocol ID
- SR419-202
- Status last verified
- Mar 2023
- First submitted
- 24 Apr 2022
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05357677
- Acronym / sponsor ID
- SR419-202
- Conditions
- Postherpetic Neuralgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Shanghai SIMR Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SR419-Placebo sequence | Experimental | Drug: SR41930 mg of SR419 administered TID for 4 weeks followed by placebo administered TID for 4 weeks |
| Placebo-SR419 sequence | Experimental | Drug: SR419placebo administered TID for 4 weeks followed by 30 mg of SR419 administered TID for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR419SR419 capsule | Drug | Placebo-SR419 sequence, SR419-Placebo sequence |
Primary outcome
Daily Average Pain Score (DAPS)
Time frame: 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.
3 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: up to Day 64
Daily Sleep Interference Score
Time frame: up to Day 64
Adverse events
Time frame: up to Day 70
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fa Bi Fan, MD principal investigator
China-Japan Friendship Hospital
Yong Cui, MD principal investigator
China-Japan Friendship Hospital
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SR419 in people with Postherpetic Neuralgia, run by Shanghai SIMR Biotechnology Co., Ltd. at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Average Pain Score (DAPS) (time frame: up to Day 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.