Efficacy and Safety of Crisugabalin in Treating Neuropathic Pain Related to Neuromyelitis Optica Spectrum Disorders: a Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled, Exploratory Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 10
- 主要终点
- Numeric Rating Scale (NRS) Pain Score
研究概览
简要总结
This study is a multicenter, prospective, randomized, double-blind, placebo-controlled exploratory investigation conducted in China.
详细描述
To evaluate the efficacy and safety of Crisugabalin, a China-developed novel third-generation calcium channel modulator, for neuropathic pain in neuromyelitis optica spectrum disorder (NMOSD). Patients are randomized 1:1 to receive Crisugabalin or placebo for 2 weeks , followed by an 8-week open-label extension period .The main questions of this study aim to answer are:
Does Crisugabalin lower pain scores after 2 weeks and 10 weeks? What medical problems do participants have when taking crisugabalin? This trial is to compare Crisugabalin to a placebo for the first 2 weeks to see if it reduces pain.
Participants will:
Take Crisugabalin or a placebo twice daily for 2 weeks (double-blind) Then take Crisugabalin for 8 more weeks (open-label) Visit the clinic at weeks 1, 2, 4, and 8 Complete questionnaires about pain, sleep, spasms, anxiety, and depression Last updated on December 2, 2025
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •**Inclusion Criteria:**
- •Subjects who meet all of the following criteria will be enrolled in this study:
- •Able to understand and voluntarily sign the written informed consent form;
- •Male or female aged between 18 years (inclusive) and 75 years;
- •Diagnosed with aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) according to the International Panel for NMO Diagnosis (IPND, 2015) criteria;
- •Patients with comorbid neuropathic pain, DN4 ≥ 4; no change in medication dosage within the past month;
- •Numeric Rating Scale (NRS) for pain score ≥ 4 at screening;
- •First-time use of Crisugabalin Capsules.
排除标准
- •Subjects who meet any of the following criteria will not be enrolled in this study:
- •Presence of peripheral neuropathy or pain unrelated to NMOSD that, in the investigator's judgment, may confound the assessment;
- •Known history of allergy to the investigational drug components, or to other drugs with similar chemical structures, or to any excipients;
- •Prior use of pregabalin ≥ 300 mg/day, gabapentin ≥ 1200 mg/day, or mirogabalin ≥ 30 mg/day with lack of clinical efficacy as judged by the investigator;
- •Severe liver or kidney function abnormalities, meeting any of the following clinical laboratory findings:
- •1) Liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × upper limit of normal (ULN); 2) Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² (calculated using the simplified MDRD formula);
- •Women who are pregnant, planning to become pregnant during the study period, or currently breastfeeding; subjects who are unwilling to use reliable contraceptive measures (including condoms, spermicides, intrauterine devices, etc.) from the time of signing the ICF until 28 days after the last dose of the investigational drug;
- •Current use of IL-6 receptor blockers (e.g., tocilizumab, satralizumab);
- •History of suicidal behavior or suicidal ideation;
- •Participation in any other clinical study within 30 days prior to screening;
- •The investigator determines that there are other situations in which participation in the study is inappropriate.
研究组 & 干预措施
Placebo group
Si meining
干预措施: Placebo+Crisugabalin (Drug)
Crisugabalin group
Si meining
干预措施: Crisugabalin (Drug)
结局指标
主要结局
Numeric Rating Scale (NRS) Pain Score
时间窗: Change from baseline in the Numeric Rating Scale (NRS) pain score after 2 and 10 weeks of treatment
Patients rate their average pain intensity over the past 24 hours on an 11-point scale (0-10), with 0 = no pain and 10 = worst possible pain. * Min / Max: 0 / 10 * Severity relationship:\*\* Higher scores indicate greater pain severity. Pain levels are categorized as: Mild (1-3), Moderate (4-6), Severe (7-10)
次要结局
- Numeric Rating Scale (NRS) response rate(Change from baseline between Crisugabalin and placebo during the 2-week and 10 -week treatment period.)
- Short-Form McGill Pain Questionnaire (SF-MPQ) score(Change from baseline in the Short-Form McGill Pain Questionnaire (SF-MPQ) score after 2 and 10 weeks of treatment)
- Daily Sleep Interference Scale (DSIS) score(Change from baseline in the Daily Sleep Interference Scale (DSIS) score after 2 and 10 weeks of treatment)
- Penn Spasm Frequency Scale (PSFS) score(Change from baseline in the Penn Spasm Frequency Scale (PSFS) score after 2 and 10 weeks of treatment)
- Hamilton Anxiety Rating Scale (HAMA) score(Change from baseline in the Hamilton Anxiety Rating Scale (HAMA) score after 2 and 10 weeks of treatment)
- Hamilton Depression Rating Scale (HAMD) score(Change from baseline in the Hamilton Depression Rating Scale (HAMD) score after 2 and 10 weeks of treatment)
- Incidence of adverse reactions(Change from baseline during 2 and 10 weeks of treatment)
- Patient Global Impression of Change (PGIC) score(Change from baseline in the Patient Global Impression of Change (PGIC) score after 10 weeks of treatment)
- EuroQol 5-Dimension 5-Level（EQ-5D-5L） score(Change from baseline in the EuroQol 5-Dimension 5-Level（EQ-5D-5L） score after 10 weeks of treatment)