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
Beijing Friendship Hospital
20 participants
Mar 10, 2026
INTERVENTIONAL
Conditions
Summary
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 Criteria4
- \. Aged 18-75 years, regardless of gender.
- \. Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) (IRLSSG criteria) or variant RLS confirmed by a neurologist.
- \. Moderate to severe RLS (IRLS score ≥11).
- \. Able to understand and comply with the study protocol, and provides written informed consent.
Exclusion Criteria8
- \. 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).
- \. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).
- \. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).
- \. Severe liver or kidney dysfunction (ALT/AST \>3×ULN, eGFR \<30mL/min/1.73m²).
- \. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).
- \. Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.
- \. Participation in other clinical trials within 1 month, inability to cooperate with follow-up, or history of substance abuse.
- \. Pregnancy or lactation.
Interventions
Participants will receive oral administration of Crisugabalin for 12 consecutive weeks. No other drugs affecting RLS symptoms will be allowed during the study. Clinical assessments and safety monitoring will be conducted at scheduled follow-up visits.
Locations(1)
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NCT07453862