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

NCT07453862 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-06

No results posted yet for this study

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

Conditions

  • Restless Leg Syndrome (RLS)
  • Variant Restless Legs Syndrome

Interventions

DRUG

Crisugabalin

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.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-10
Primary Completion
2027-06-30
Completion
2027-08-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07453862 on ClinicalTrials.gov