Restless Leg Syndrome (RLS), Variant Restless Legs Syndrome
Conditions
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
Interventions
DRUGCrisugabalin
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
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Restless Legs Syndrome Scale (IRLS) Score from Baseline to Week 12 | Baseline (pre-treatment) and Week 12 (end of treatment) | The International Restless Legs Syndrome Scale (IRLS) is a 10-item scale used to assess the severity of restless legs syndrome symptoms, including urge to move, sleep disturbance, and daytime impairment. The scale ranges from 0 to 40 points, with lower scores indicating less severe symptoms and a score of 0 indicating no symptoms. This outcome measure assesses the absolute change in IRLS total score from baseline (pre-treatment) to Week 12 (end of treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Restless Legs Syndrome Quality of Life (QoL-RLS) Score from Baseline to Week 12 | Baseline (pre-treatment) and Week 12 (end of treatment) | This outcome evaluates the effect of treatment on participants' quality of life, focusing on physical, emotional, and social functioning related to RLS symptoms. The Restless Legs Syndrome Quality of Life (QoL-RLS) scale is a disease-specific instrument designed to measure the impact of RLS on daily life. The scale ranges from 0 to 100 points, with higher scores indicating better quality of life related to RLS symptoms. This outcome measure assesses the change in QoL-RLS total score from baseline (pre-treatment) to Week 12 (end of treatment). |
Countries
China
Contacts
CONTACTWenlu Zhao
Outcome results
None listed