NCT07199504 A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole
| NCT ID | NCT07199504 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Yunfeng Xia |
| Condition | Restless Leg Syndrome Due to Uraemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2025-09-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07199504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Restless Leg Syndrome Due to Uraemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07199504 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07199504 currently recruiting?
Yes, NCT07199504 is actively recruiting participants. Contact the research team at yunfengxia0920@126.com for enrollment information.
Where is the NCT07199504 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07199504 clinical trial?
NCT07199504 is sponsored by Yunfeng Xia. The trial plans to enroll 80 participants.