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Postherpetic NeuralgiaPhase 3NCT05140863

To Evaluate the Efficacy and Safety of HSK16149 Capsule in Chinese Patients With Postherpetic Neuralgia

A Phase 3 study testing HSK16149 20mg BID and HSK16149 40mg BID in people with Postherpetic Neuralgia, run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Postherpetic Neuralgia
What is being tested?
HSK16149 20mg BID and HSK16149 40mg BID
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
372 participants
Where
2 sitesChina
Study dates
1 Nov 2021to 5 Jan 2023
Phase
Phase 3
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent;
  • Males or females aged 18-75 years of age inclusive;
  • Outpatient, Patients can not stay in the hospital overnight;
  • Patients must have pain present for more than 1 months after the healing of the herpes zoster skin rash;
  • At Screening, pain scale (VAS) of ≥40 mm;

Who cannot join

  • Peripheral neuropathy or pain unrelated to PHN that may confuse the assessment of PHN;
  • Skin conditions in the area affected by neurupathy that could alter sensation;
  • Chronic systemic diseases that may affect subjects' participation in the study;
  • Severe hematologic, hepatic or renal dysfunction, the subject will be excluded if:1)Neutrophils < 1.5 × 109/L, or platelet < 90 × 109/L, or hemoglobin < 100 g/L, or 2)AST/ALT > 2.5 × upper limit of normal (ULN), or TBIL > 1.5 × ULN, or 3)Estimation of glomerular filtration rate (eGFR) < 60 mL/min / 1.73 m2, or 4)Creatine kinase > 2.0 × ULN.
  • Uncontrolled diabetes(HbA1c≥11.0% at screening) ;
  • History of substance abuse or alcohol abuse;
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  • Any active infections at screening;
  • HBsAg or HCV Ab positive, or HIV Ab positive, or serum TP Ab positive;
  • Inability or unwillingness to discontinue any other prohibited concomitant medications (see Section 6.3);
  • Patients who have undergone neurolytic or neurosurgical therapy 1 week before screening for postherpetic neuralgia;
  • Failure to response to previous treatment with pregabalin at doses ≥ 300 mg/d or gabapentin at doses ≥ 1200 mg/d for treatment of PHN;
  • History of allergic or medically significant adverse reaction to investigational products or their excipients, acetaminophen or related compounds;
  • History of suicidal behavior or attempted suicide;
  • Pregnant or preparing for pregnancy or breastfeeding during the study period, or subjects were not willing to use reliable contraceptives methods from the date of ICF signature until 28 days after the last trial drug administration, or planning to use progesterone contraceptives during this period;
  • Mechanical operators who are engaged in high-altitude operations, motor vehicle driving and other dangerous machinery operators;
  • Participated in another clinical study within 30 days prior to screening;
  • Other conditions unlikely to participate in this trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi, 330006

  • Dermatology Hospital of Chinese Academy of Medical Sciences

    Nanjing, Jiangsu, 210042

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 12-Week, Phase 3 Study to Evaluate the Efficacy and Safety of HSK16149 Capsules in Chinese Patients With Postherpetic Neuralgia

Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo

Being tested
HSK16149 20mg BID, HSK16149 40mg BID, Placebo BID
Medical subject headings
Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HSK16149 20mg BIDDrug

    HSK16149 20mg, orally twice a day, treatment period; 12-weeks fixed dose

  • HSK16149 40mg BIDDrug

    HSK16149 40mg, orally twice a day, treatment period; 12-weeks fixed dose

  • Placebo BIDDrug

    Placebo, orally twice a day, treatment period; 12-weeks fixed dose

Study groups in NCT05140863
Study groupRoleWhat they receive
HSK16149 20mg BIDExperimentalHSK16149 20mg, orally twice a day for 12 weeks
Receives: Drug: HSK16149 20mg BID
HSK16149 40mg BIDExperimentalHSK16149 40mg, orally twice a day for 12 weeks
Receives: Drug: HSK16149 40mg BID
Placebo BIDPlacebo comparatorplacebo, orally twice a day for 12 weeks
Receives: Drug: Placebo BID

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the change from baseline in ADPS between HSK16149 and placebo at week 12

    The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries

    Measured: Baseline and week 12

Secondary outcomes (10)

  1. Compare the response rate between HSK16149 and placebo at week 12 (Proportion of subjects whose ADPS decreased by ≥30% and ≥50% from baseline )

    Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.

    Measured: Baseline and week 12

  2. Compare the change from baseline in ADPS between HSK16149 and placebo at week 1 to 12

    The mean change in average daily pain score (ADPS) was measured using a 11-point numeric rating scale (NRS; 0 [no pain] to 10 [worst possible pain]. The rating averaged over a 7-day period and was based on entries in patients' daily pain diaries

    Measured: From week 1 to week 12

  3. Compare the change from baseline in Visual Analogue Scale（VAS） between HSK16149 and placebo at week 12

    VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain

    Measured: Baseline and week 12

  4. Compare the change from baseline in Short Form McGill Pain Questionnaire (SF-MPQ) between HSK16149 and placebo at week 12

    Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score:

    Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe)

    Part 2 - a visual analog scale (VAS), in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain

    Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)

    Measured: Baseline and week 12

  5. Compare the change from baseline in Average Daily Sleep interference score（ADSIS） between HSK16149 and placebo at week 12

    he sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores

    Measured: Baseline and week 12

  6. Compare the total consumption of Acetaminophen and Paracetamol and Dihydrocodeine Tartrate between HSK16149 and placebo during the trial

    Measured: From week 1 to week 12

  7. Compare the change from baseline in EQ-5D-5L between HSK16149 and placebo at week 12

    The change from baseline in total EuroQol-5-Domain-5-Level health questionnaire

    Measured: Baseline and week 12

  8. AE（adverse event） to evaluate the safety of HSK16149 during the trial

    Number and severity of AEs

    Measured: From week 1 to week 12

  9. Peak Plasma Concentration (Cmax) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia

    Measured: Week 4,week 8,week 10,week 12

  10. Area under the plasma concentration versus time curve (AUC) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia

    Measured: Week 4,week 8,week 10,week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2021
  2. Study start1 Nov 2021
  3. Primary completion22 Dec 2022
  4. Study completion5 Jan 2023

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140863
Sponsor's protocol ID
HSK16149-302
Status last verified
Feb 2023
First submitted
14 Oct 2021
Last updated
27 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang D, Lei T, Qin L, Li C, Lin X, Wang H, Zhang G, Zhang S, Shi K, Li L, Yang Z, Yang X, Ba X, Gao Y, Zhang Z, Wang G, Wu L, Wang Y, Wang Y, Zhu S, Shi J, Ye Z, Yang C, Liu C, Zhang T, Lu S, Yu N, Li X, Han X, Chen X, Wan L, Cheng Z, Bai N, Jin Z, Yu C, Zhang W, Lu J, Wang D, Sun H, Wu W, Qin P, Feng Z, Chen R, Zhang T, Yang D, Yin W, Zhang J, Li X, Li F, Wu T, Lu Q. Efficacy and Safety of Crisugabalin (HSK16149) in Adults with Postherpetic Neuralgia: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2024 Nov 1;160(11):1182-1191. doi: 10.1001/jamadermatol.2024.3410.

    PubMed 39320907

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HSK16149 20mg BID and HSK16149 40mg BID in people with Postherpetic Neuralgia, run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.

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 17 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Compare the change from baseline in ADPS between HSK16149 and placebo at week 12 (time frame: Baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05140863, which also lists 1 linked publication.

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 27 Feb 2023.

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