NCT06422117

Efficacy and Safety of HSK16149 Capsule in the Treatment of Moderate and Severe Central Neuropathic Pain in China

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
DRUG	HSK16149 20mg-40mg BID	Oral, 20mg, BID, adjustable to 40mg, BID based on tolerability and efficacy;
DRUG	Placebo	Placebo, oral, 2 capsules twice daily

Timeline

• Start date: 2024-05-30
• Primary completion: 2027-07-30
• Completion: 2027-08-07
• First posted: 2024-05-20
• Last updated: 2024-05-20