[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"variant-restless-legs-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:variant-restless-legs-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100627840","phase-1-novel-calcium-channel-modulators-in-rls-and-variants-efficacy--safety-100627840",false,"NCT07453862","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","Inclusion Criteria:\n\n* 1\\. Aged 18-75 years, regardless of gender.\n* 2\\. Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) (IRLSSG criteria) or variant RLS confirmed by a neurologist.\n* 3\\. Moderate to severe RLS (IRLS score ≥11).\n* 4\\. Able to understand and comply with the study protocol, and provides written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Secondary RLS (e.g., iron deficiency anemia with serum ferritin \\\u003C30μg\u002FL, renal dysfunction with eGFR \\\u003C30ml\u002Fmin, pregnancy\u002Flactation, drug-induced RLS with unadjustable medications).\n* 2\\. Severe central nervous system diseases (e.g., status epilepticus, severe dementia, stroke within 3 months).\n* 3\\. Severe cardiovascular diseases (e.g., congestive heart failure, uncontrolled hypertension with SBP≥180mmHg or DBP≥110mmHg).\n* 4\\. Severe liver or kidney dysfunction (ALT\u002FAST \\>3×ULN, eGFR \\\u003C30mL\u002Fmin\u002F1.73m²).\n* 5\\. Active mental illnesses (e.g., schizophrenia, acute bipolar disorder).\n* 6\\. Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.\n* 7\\. Participation in other clinical trials within 1 month, inability to cooperate with follow-up, or history of substance abuse.\n* 8\\. Pregnancy or lactation.","ALL","18 Years","75 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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\u002Fprimary 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\u002Fare\\]:\n\n* 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?\n* What is the safety profile (incidence of adverse events) of this calcium channel modulator in RLS patients?\n\nParticipants will \\[describe the main tasks participants will be asked to do, interventions they'll be given\\]:\n\n* Receive oral administration of the novel calcium channel modulator (40mg twice daily) for 12 consecutive weeks\n* Complete scheduled follow-up visits for symptom assessments, safety monitoring, and questionnaire completion",[27,28],"Restless Leg Syndrome (RLS)","Variant Restless Legs Syndrome","RECRUITING","2026-03-03",{"date":32,"type":33},"2026-03-06","ACTUAL",{"date":35,"type":21},"2026-03-10",{"date":37,"type":21},"2027-08-31",{"name":39,"class":40},"Beijing Friendship Hospital","OTHER"]