Dipyridamole for restless legs in people with uremia on hemodialysis
A Self-Controlled Study on the Treatment of Restless Legs Syndrome in Uremia With Dipyridamole
This trial will test whether taking dipyridamole 50 mg three times a day for 12 weeks can reduce restless legs symptoms and improve sleep and mood in adults with uremia on maintenance hemodialysis.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT07199504 on ClinicalTrials.gov |
What this trial studies
This is a single-center, self-controlled interventional study in which all participants receive dipyridamole 50 mg three times daily for 12 weeks and outcomes are compared before and after treatment. About 80 maintenance hemodialysis patients with moderate-to-severe restless legs syndrome (IRLS score >15) were enrolled and had baseline clinical data and laboratory tests collected. Key outcomes include changes in IRLS, sleep quality (PSQI), depression and anxiety scales (HAM-D, HAM-A), KDQOL-36 quality of life scores, and laboratory markers such as serum iron, ferritin, PTH, hemoglobin, and dialysis adequacy. Adverse events including bleeding, nausea, headache, dizziness, diarrhea, insomnia, and fatigue were monitored throughout the treatment period.
Who should consider this trial
Good fit: Adults aged 18–75 on maintenance hemodialysis for at least 3 months with RLS and an IRLS score greater than 15 who are willing to take dipyridamole and attend follow-up visits are ideal candidates.
Not a fit: Patients with active bleeding, recent use of medications that affect RLS, a history of psychosis, allergy to dipyridamole, pregnancy or breastfeeding, or other movement disorders affecting assessment are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, dipyridamole could reduce RLS symptoms and improve sleep, mood, and quality of life for hemodialysis patients with uremia.
How similar studies have performed: Use of dipyridamole specifically for uremic RLS is relatively novel with limited published evidence, while other drug classes have been more widely studied for RLS.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chongqing, Chongqing Municipality
- First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
Study contacts
- Study coordinator: yunfeng xia
- Email: yunfengxia0920@126.com
- Phone: 86-023-89012687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.