RecruitingPhase 1

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

China20 participantsStarted 2026-03-10

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12

Timeframe: Baseline (pre-treatment) and Week 12 (end of treatment)

Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12

Timeframe: Baseline (pre-treatment) and Week 12 (end of treatment)

Trial details

NCT IDNCT07453862

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Wenlu Zhao

13017688128 912977992@qq.com

View on ClinicalTrials.gov More Restless Leg Syndrome (RLS) trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12

Timeframe: Baseline (pre-treatment) and Week 12 (end of treatment)

Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12

Timeframe: Baseline (pre-treatment) and Week 12 (end of treatment)