NCT07453862 Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety
| NCT ID | NCT07453862 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing Friendship Hospital |
| Condition | Restless Leg Syndrome (RLS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-03-10 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-03-10 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07453862 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Restless Leg Syndrome (RLS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07453862 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07453862 currently recruiting?
Yes, NCT07453862 is actively recruiting participants. Contact the research team at 912977992@qq.com for enrollment information.
Where is the NCT07453862 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07453862 clinical trial?
NCT07453862 is sponsored by Beijing Friendship Hospital. The trial plans to enroll 20 participants.