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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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
Trial Details
NCT Number NCT07453862
Lead Sponsor Beijing Friendship Hospital
Conditions
(from sponsor)
Restless Leg Syndrome (RLS), Variant Restless Legs Syndrome
Related terms Restless Legs Syndrome
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov