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

Recruiting now · Phase 1

Conditions studied: Restless Leg Syndrome (RLS), Variant Restless Legs Syndrome

In brief

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

Key facts

Study ID

NCT07453862

Run by

Beijing Friendship Hospital

People needed

20

Starts

2026-03-10

Expected to finish

2027-08-31

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Capital Medical University Affiliated Beijing Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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