A Phase 2/3 interventional study of Dipyridamole 50mg tid in Restless Leg Syndrome Due to Uraemia, sponsored by Yunfeng Xia. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Yunfeng Xia · Phase 2/3, Interventional, and Treatment
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.
This study is a self-controlled study in which all participants received active drug treatment for 6 months. The efficacy and safety of dipyridamole were evaluated by comparing changes in relevant scale scores before and after treatment. The study screened patients receiving maintenance hemodialysis at the Hemodialysis Center of the First Affiliated Hospital of Chongqing Medical University, with a baseline score of greater than 15 on the International Restless Legs Syndrome Rating Scale (IRLS). Approximately 80 patients met the inclusion criteria of the study and were willing to sign informed consent. General clinical data and pre-study laboratory parameters were collected, including age, sex, body mass index, serum iron, ferritin, serum parathyroid hormone, hemoglobin, albumin, dialysis adequacy, IRLS, Pittsburgh Sleep Quality Index, Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, and KDQOLTM-36. All enrolled patients were instructed to take dipyridamole tablets orally at a dose of 50 mg three times daily for 12 weeks. During the study, the occurrence of drug-related adverse reactions such as nausea, headache, dizziness, diarrhea, insomnia, fatigue, and bleeding was also recorded. At the end of the treatment period, general clinical data, laboratory parameters, and relevant scale assessment results were collected again.
(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.
Participants will: Take dipyridamole daily (50mg each time, three times a day) for 12 weeks
Drug: Dipyridamole 50mg tid
Participants will take dipyridamole daily (50mg each time, three times a day) for 12 weeks
International Restless Legs Syndrome Study Group rating scale
The treatment effect on participants' restless legs syndrome is mainly assessed through their scores on the International Restless Legs Syndrome Study Group rating scale before and after treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Hamilton Depression Rating Scale
The changes in participants' depressive symptoms were assessed using the Hamilton Depression Rating Scale before and after they received treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Hamilton Anxiety Scale
The changes in participants' anxiety levels were assessed using the Hamilton Anxiety Scale before and after they received treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Pittsburgh Sleep Quality Index
The changes in participants' sleep quality were assessed using the Pittsburgh Sleep Quality Index before and after they received treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
KDQOL-36 Scale
Changes in participants' quality of life were assessed using the KDQOL-36 Scale before and after they received treatment.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: Undecided
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Yunfeng Xia