Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07453862

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

Led by Beijing Friendship Hospital · Updated on 2026-03-06

20

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-75 years, regardless of gender.
  • Meets the diagnostic criteria for typical Restless Legs Syndrome (RLS) or variant RLS confirmed by a neurologist.
  • Moderate to severe RLS with an IRLS score of 11 or higher.
  • Able to understand, comply with the study protocol, and provide written informed consent.
Not Eligible

You will not qualify if you...

  • Secondary RLS due to iron deficiency anemia (serum ferritin <30 µg/L), renal dysfunction (eGFR <30 ml/min), pregnancy, lactation, or drug-induced RLS with unadjustable medications.
  • Severe central nervous system diseases such as status epilepticus, severe dementia, or stroke within the past 3 months.
  • Severe cardiovascular diseases including congestive heart failure or uncontrolled hypertension (SBP ≥180 mmHg or DBP ≥110 mmHg).
  • Severe liver or kidney dysfunction (ALT/AST >3×ULN, eGFR <30 mL/min/1.73 m²).
  • Active mental illnesses like schizophrenia or acute bipolar disorder.
  • Hypersensitivity to Keligabalin Benzenesulfonic Acid or its excipients.
  • Participation in other clinical trials within the last month, inability to cooperate with follow-up, or history of substance abuse.
  • Pregnancy or lactation.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Capital Medical University Affiliated Beijing Friendship Hospital

Beijing, Beijing Municipality, China, 100050

Actively Recruiting

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Research Team

W

Wenlu Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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