Observation of Efficacy and Safety of Novel Calcium Channel Modulators in the Treatment of Restless Legs Syndrome and Its Variant Subtypes
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
研究概览
简要总结
The goal of this [study type: clinical trial] is to [primary purpose: evaluate the efficacy and safety of a novel calcium channel modulator in treating Restless Legs Syndrome (RLS) and its variant subtypes] in [describe participant population/primary condition: adult patients aged 18-75 years with confirmed RLS or its variant subtypes, who meet the study's eligibility criteria]. The main question[s] it aims to answer [is/are]:
- Does the novel calcium channel modulator improve RLS-related symptoms (assessed by the International Restless Legs Syndrome Study Group Rating Scale, IRLS) after the treatment period?
- What is the safety profile (incidence of adverse events) of this calcium channel modulator in RLS patients?
Participants will [describe the main tasks participants will be asked to do, interventions they'll be given]:
- Receive oral administration of the novel calcium channel modulator (40mg twice daily) for 12 consecutive weeks
- Complete scheduled follow-up visits for symptom assessments, safety monitoring, and questionnaire completion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •1. Aged 18-75 years, regardless of gender.
- •2. Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) (IRLSSG criteria) or variant RLS confirmed by a neurologist.
- •3. Moderate to severe RLS (IRLS score ≥11).
- •4. Able to understand and comply with the study protocol, and provides written informed consent.
排除标准
- •1. Secondary RLS (e.g., iron deficiency anemia with serum ferritin <30μg/L, renal dysfunction with eGFR <30ml/min, pregnancy/lactation, drug-induced RLS with unadjustable medications).
- •2. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).
- •3. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).
- •4. Severe liver or kidney dysfunction (ALT/AST >3×ULN, eGFR <30mL/min/1.73m²).
- •5. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).
- •6. Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.
- •7. Participation in other clinical trials within 1 month, inability to cooperate with follow-up, or history of substance abuse.
- •8. Pregnancy or lactation.
研究组 & 干预措施
Crisugabalin Treatment Arm
干预措施: Crisugabalin (Drug)
结局指标
主要结局
Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12
时间窗: Baseline (pre-treatment) and Week 12 (end of treatment)
The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms and a score of 0 indicating no symptoms. This outcome measure assesses the absolute change in IRLS total score from baseline (pre-treatment) to Week 12 (end of treatment).
次要结局
- Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12(Baseline (pre-treatment) and Week 12 (end of treatment))