Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety

Observation of Efficacy and Safety of Novel Calcium Channel Modulators in the Treatment of Restless Legs Syndrome and Its Variant Subtypes

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

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.