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

NCT07199504 | Recruiting Phase 2

• 2 other identifiers: 2025-451-02CYYY-SSCX202522
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Leg Syndrome Due to Uraemia

Keywords

Restless Leg Syndrome; Uraemia

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (4)

• Hamilton Depression Rating Scale

  From enrollment to the end of treatment at 12 weeks

• Hamilton Anxiety Scale

  From enrollment to the end of treatment at 12 weeks

• Pittsburgh Sleep Quality Index

  From enrollment to the end of treatment at 12 weeks

• KDQOL-36 Scale

  From enrollment to the end of treatment at 12 weeks

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Dipyridamole 50mg tid

Interventions

Dipyridamole 50mg tid DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Yunfeng Xia: lead

Study Sites (1)

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome; Uremia

Interventions

Dipyridamole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

yunfeng xia

CONTACT

86-023-89012687; yunfengxia0920@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician of Nephrology、Clinical Professor

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 30, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)