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NCT Number: NCT07199504

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

yunfeng xia

CONTACT

[email protected]

86-023-89012687

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dipyridamole 50mg tid

Drug

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

Primary outcomes

  1. International Restless Legs Syndrome Study Group rating scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

Secondary outcomes

  1. Hamilton Depression Rating Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    The changes in participants' depressive symptoms were assessed using the Hamilton Depression Rating Scale before and after they received treatment.

  2. Hamilton Anxiety Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    The changes in participants' anxiety levels were assessed using the Hamilton Anxiety Scale before and after they received treatment.

  3. Pittsburgh Sleep Quality Index

    Time frame: From enrollment to the end of treatment at 12 weeks

    The changes in participants' sleep quality were assessed using the Pittsburgh Sleep Quality Index before and after they received treatment.

  4. KDQOL-36 Scale

    Time frame: From enrollment to the end of treatment at 12 weeks

    Changes in participants' quality of life were assessed using the KDQOL-36 Scale before and after they received treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

yunfeng xia

CONTACT

[email protected]

86-023-89012687

Sponsors and collaborators

Lead sponsor

Yunfeng Xia

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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