Overview
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
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
