A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole
Recruiting now · Phase 2/Phase 3
Conditions studied: Restless Leg Syndrome Due to Uraemia
In brief
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.
Key facts
- Study ID
- NCT07199504
- Run by
- Yunfeng Xia
- People needed
- 80
- Starts
- 2025-09-20
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (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.
You may not qualify if…
- (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.
Where it is running
- First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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