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Investigate the Efficacy and Safety of HSK16149 capsules in Chinese Postherpetic Neuralgia Following 12 Weeks Treatment in Comparison to Placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK16149 20mg BID | Experimental | HSK16149 20mg, orally twice a day for 12 weeks |
|
| HSK16149 40mg BID | Experimental | HSK16149 40mg, orally twice a day for 12 weeks |
|
| Placebo BID | Placebo Comparator | placebo, orally twice a day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK16149 20mg BID | Drug | HSK16149 20mg, orally twice a day, treatment period; 12-weeks fixed dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Hospital of Chinese Academy of Medical Sciences | Nanjing | Jiangsu | 210042 | China | ||
| The First Affiliated Hospital Of Nanchang University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39320907 | Derived | 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. |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| HSK16149 40mg BID | Drug | HSK16149 40mg, orally twice a day, treatment period; 12-weeks fixed dose |
|
| Placebo BID | Drug | Placebo, orally twice a day, treatment period; 12-weeks fixed dose |
|
| 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 | From week 1 to week 12 |
| 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 | Baseline and week 12 |
| 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) | Baseline and week 12 |
| 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 | Baseline and week 12 |
| Compare the total consumption of Acetaminophen and Paracetamol and Dihydrocodeine Tartrate between HSK16149 and placebo during the trial | From week 1 to week 12 |
| 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 | Baseline and week 12 |
| AE(adverse event) to evaluate the safety of HSK16149 during the trial | Number and severity of AEs | From week 1 to week 12 |
| Peak Plasma Concentration (Cmax) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia | Week 4,week 8,week 10,week 12 |
| Area under the plasma concentration versus time curve (AUC) of HSK16149 capsules in Chinese patients with Postherpetic Neuralgia | Week 4,week 8,week 10,week 12 |
| Nanchang |
| Jiangxi |
| 330006 |
| China |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |