Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of HSK16149 capsule in the treatment of moderate to severe central neuropathic pain compared with placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Placebo,Oral,2 capsules, twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK16149 20mg-40mg BID | Drug | Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy; |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40316144 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo, oral, 2 capsules twice daily |
|