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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years – 75 Years

Sex

ALL

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)