RecruitingPhase 1NCT07453862

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

Sponsor

Beijing Friendship Hospital

Enrollment

20 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

Restless Leg Syndrome (RLS)Variant Restless Legs Syndrome

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests the effectiveness and safety of a new medication called Keligabalin Benzenesulfonic Acid—a type of calcium channel modulator (a drug that affects nerve signals)—for treating restless legs syndrome (RLS), an uncomfortable urge to move the legs that is often worse at night and disrupts sleep. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with restless legs syndrome by a neurologist - Your RLS is moderate to severe (score of 11 or higher on the standard RLS severity scale) **You may NOT be eligible if...** - Your RLS is caused by another condition such as iron deficiency anemia (very low iron stores), kidney disease, pregnancy, or medications you cannot stop - You have severe epilepsy, recent stroke, or significant dementia - You have severe heart failure or very high uncontrolled blood pressure - You have severe liver or kidney disease - You are pregnant or breastfeeding - You have a known allergy to the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCrisugabalin

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)

Capital Medical University Affiliated Beijing Friendship Hospital

Beijing, Beijing Municipality, China

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NCT07453862

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