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

NCT ID: NCT07199504

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-12-31

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 6 months. 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.

Detailed Description

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 6 months. 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.

Conditions

Restless Leg Syndrome Due to Uraemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants will: Take dipyridamole daily (50mg each time, three times a day) for 6 months

Participants will: Take dipyridamole daily (50mg each time, three times a day) for 6 months

Group Type: EXPERIMENTAL

Dipyridamole 50mg tid

Intervention Type: DRUG

Participants will take dipyridamole daily (50mg each time, three times a day) for 6 months

Interventions

Dipyridamole 50mg tid

Participants will take dipyridamole daily (50mg each time, three times a day) for 6 months

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunfeng Xia

OTHER

Sponsor Role: lead

Responsible Party

Yunfeng Xia

Chief Physician of Nephrology、Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

CYYY-SSCX202522

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-451-02

Identifier Type: -

Identifier Source: org_study_id