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NCT07453862

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

Recruiting now Phase 1 Last updated 6 March 2026
What this trial tests

Phase 1 trial testing Crisugabalin in Restless Leg Syndrome (RLS) in 20 participants. Currently enrolling.

Timeline
10 March 2026
Primary endpoint
30 June 2027
31 August 2027

Quick facts

Lead sponsorBeijing Friendship Hospital
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date10 March 2026
Primary completion30 June 2027
Estimated completion31 August 2027
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Beijing Friendship Hospital

Who can join

Adults 18 to 75, any sex, with Restless Leg Syndrome (RLS) or Variant Restless Legs Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Crisugabalin

Trials testing the same drug.

Other recruiting trials for Restless Leg Syndrome (RLS)

Currently open trials in the same condition.

Other Beijing Friendship Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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