RecruitingPhase 2Phase 3NCT07199504

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

Sponsor

Yunfeng Xia

Enrollment

80 participants

Start Date

Sep 20, 2025

Study Type

INTERVENTIONAL

Conditions

Restless Leg Syndrome Due to Uraemia

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria1

(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 Criteria1

(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.

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Interventions

DRUGDipyridamole 50mg tid

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

Locations(1)

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

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NCT07199504