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Clinical Trials in China / NCT07199504
Recruiting Phase 2/3

A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole

NCT07199504 · tracked via the Priya Life Science China tracker
Sponsor
Yunfeng Xia
Phase
Phase 2/3
Started
2025-09-20
Last updated
2026-04-22

Condition(s) studied

Restless Leg Syndrome Due to Uraemia

Investigational drug(s) / intervention(s)

Dipyridamole 50mg tid

Dipyridamole 50mg tid: Participants will take dipyridamole daily (50mg each time, three times a day) for 12 weeks

Study summary

The purpose of this clinical trial is to determine whether dipyridamole can treat restless legs syndrome in patients with uremia. In addition, the safety of dipyridamole will also be evaluated. The main questions this study aims to answer include: Can dipyridamole improve the symptoms of restless legs syndrome in participants? Can dipyridamole improve participants' anxiety, depression, sleep quality, and quality of life? What adverse reactions might participants experience while taking dipyridamole? This study is a self-controlled trial in which all participants receive active drug treatment. Participants will take dipyridamole daily (50 mg per dose, three times a day) for 12 weeks. The efficacy of dipyridamole will be evaluated by comparing relevant scale scores and laboratory indicators before and after treatment. In addition, adverse reactions during the treatment follow-up will be monitored to assess the safety of dipyridamole in this patient population.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: (1) Maintenance hemodialysis for ≥3 months;(2) Age between 18-75 years;(3) Diagnosed with Restless Legs Syndrome (RLS) according to IRLSSG standards with a score \>15;(4) Willing to cooperate with this study. Exclusion Criteria: (1). Patients with other cerebrovascular, muscular, and movement system diseases affecting the assessment of RLS;(2). Patients with active bleeding, such as gastrointestinal bleeding or intracerebral hemorrhage;(3). Patients who have been on dipyridamole for a long time;(4). Patients who have taken other medications that may affect RLS in the last 3 weeks, such as dopamine agonists/antagonists, tricyclic antidepressants, lithium, etc.;(5). Patients with a history of psychosis;(6). Pregnant or breastfeeding women;(7). Patients who are allergic or intolerant to dipyridamole;(8). Patients who cannot or are unwilling to cooperate with this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting

More Yunfeng Xia trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07199504 on ClinicalTrials.gov ↗ ← All trials in China