Central Neuropathic PainPhase 3NCT06422117
Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China
A Phase 3 study testing HSK16149 20mg-40mg BID in people with Central Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd..
Trial summary
To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Neuropathic Pain
- What is being tested?
- HSK16149 20mg-40mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2024to 7 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Voluntarily sign an informed consent form;
- Able to read and complete survey questionnaires;
- Male or female patients aged ≥ 18 years old;
- The subject has a medical history and symptoms related to central neuropathic pain, including spinal cord related neuropathic pain (subject enrollment ≥ 50%), post-stroke central neuropathic pain, Parkinson's disease pain, and multiple sclerosis pain, and must meet the following criteria: a) pain duration ≥ 3 months; b) Characteristics that conform to neuropathic pain: DN4 scale score ≥ 4 points;
- During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of ≥ 40 mm over the past 24 hours.
Who cannot join
- The presence of other painful diseases that may affect the evaluation of neuropathic pain;
- Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment;
- There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study；
- Meet any of the following laboratory test results: a) Hematology: WBC<3×109/L, N< 1.5 ×109/L, PLT< 75 ×109/L, or HB< 90 g/L; b) Liver function: ALT or AST> 2.5 × ULN; Or TBIL> 1.5 × ULN; c) eGFR< 60 mL/min/1.73 m2; d) Creatine kinase > 2.0 × ULN;
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
- Mechanical operators engaged in high-altitude work, motor vehicle driving and other dangerous activities during the study period;
- Participated in any other clinical study within 30 days prior to screening;
- The investigator determined that there were other conditions that were not suitable for study participation.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate to Severe Central Neuropathic Pain in China
To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.
- Conditions
- Central Neuropathic Pain
- Being tested
- HSK16149 20mg-40mg BID, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK16149 20mg-40mg BIDDrug
Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;
PlaceboDrug
Placebo, oral, 2 capsules twice daily
| Study group | Role | What they receive |
|---|---|---|
| HSK16149 20mg-40mg bid | Experimental | Oral administration of 20mg twice daily for 12 weeks can be adjusted to 40mg twice daily based on the efficacy and tolerability of the subject Receives: Drug: HSK16149 20mg-40mg BID |
| Placebo | Placebo comparator | Placebo,Oral,2 capsules, twice daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline
Changes in mean pain intensity (ADPS) at week 12 between HSK16149 and placebo were compared from baseline;The pain NRS score divides a straight line into 10 segments, with 0 to 10 indicating pain (a total of 11 points), 0 indicating no pain, and 10 indicating the most intense pain. The pain NRS scores of the past 7 days were collected and the average value was used as the ADPS score.
Measured: week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start30 May 2024 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion7 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06422117
- Sponsor's protocol ID
- HSK16149-305
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gou X, Liu Y, Ye Q, He L, Chen Y, Dong Y, Meng Q, Shi Z, Li Y, Lu Y, Wang J, Zeng L. Crisugabalin, a ligand for the alpha2delta subunit of voltage-gated calcium channels, exhibits no obvious abuse potential in rodents. Pharmacol Biochem Behav. 2025 Jul;252:174015. doi: 10.1016/j.pbb.2025.174015. Epub 2025 May 1.
PubMed 40316144
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate to Severe Central Neuropathic Pain in China
- ClinicalTrials.gov ID
- NCT06422117
- Acronym / sponsor ID
- HSK16149-305
- Conditions
- Central Neuropathic Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 May 2024 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 7 Aug 2027 (estimated)
- First posted
- 20 May 2024 (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.
To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK16149 20mg-40mg bid | Experimental | Drug: HSK16149 20mg-40mg BIDOral administration of 20mg twice daily for 12 weeks can be adjusted to 40mg twice daily based on the efficacy and tolerability of the subject |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo,Oral,2 capsules, twice daily for 12 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)
- Voluntarily sign an informed consent form;
- Able to read and complete survey questionnaires;
- Male or female patients aged ≥ 18 years old;
- The subject has a medical history and symptoms related to central neuropathic pain, including spinal cord related neuropathic pain (subject enrollment ≥ 50%), post-stroke central neuropathic pain, Parkinson's disease pain, and multiple sclerosis pain, and must meet the following criteria: a) pain duration ≥ 3 months; b) Characteristics that conform to neuropathic pain: DN4 scale score ≥ 4 points;
- During screening visits, patients were assessed to have an average pain visual analogue scale (VAS) score of ≥ 40 mm over the past 24 hours.
Key exclusion criteria (8 listed)
- The presence of other painful diseases that may affect the evaluation of neuropathic pain;
- Patients with spinal cord injury or stroke whose condition is unstable and is expected to require surgical treatment;
- There is a chronic systemic disease that the investigator has assessed may affect the participant's participation in the study；
- Meet any of the following laboratory test results: a) Hematology: WBC<3×109/L, N< 1.5 ×109/L, PLT< 75 ×109/L, or HB< 90 g/L; b) Liver function: ALT or AST> 2.5 × ULN; Or TBIL> 1.5 × ULN; c) eGFR< 60 mL/min/1.73 m2; d) Creatine kinase > 2.0 × ULN;
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding; Women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or Iuds) for 28 days after signing up for the ICF from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period;
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 |
|---|---|---|
| HSK16149 20mg-40mg BIDOral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy; | Drug | HSK16149 20mg-40mg bid |
| PlaceboPlacebo, oral, 2 capsules twice daily | Drug | Placebo |
Primary outcome
The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline
Time frame: week12
Changes in mean pain intensity (ADPS) at week 12 between HSK16149 and placebo were compared from baseline;The pain NRS score divides a straight line into 10 segments, with 0 to 10 indicating pain (a total of 11 points), 0 indicating no pain, and 10 indicating the most intense pain. The pain NRS scores of the past 7 days were collected and the average value was used as the ADPS score.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 40316144Gou X, Liu Y, Ye Q, He L, Chen Y, Dong Y, Meng Q, Shi Z, Li Y, Lu Y, Wang J, Zeng L. Crisugabalin, a ligand for the alpha2delta subunit of voltage-gated calcium channels, exhibits no obvious abuse potential in rodents. Pharmacol Biochem Behav. 2025 Jul;252:174015. doi: 10.1016/j.pbb.2025.174015. Epub 2025 May 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSK16149 20mg-40mg BID in people with Central Neuropathic Pain, run by Haisco Pharmaceutical Group Co., Ltd..
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 8 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: opening soon, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
The changes of pain scores after treatment in HSK16149 group and placebo group were compared with baseline (time frame: week12). 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 NCT06422117, 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 20 May 2024.