Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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A randomized, double-blind controlled Study from a single center to evaluate the effect and safety of pramipexole on peritoneal dialysis patients with restless legs syndrome

Detailed Description
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Peritoneal dialysis patients diagnosed with restless legs syndrome will be divided into experiment group and control group, and will be prescribed with pramipexole and placebo respectively.After 12 weeks, we will compare IRLSSG（International RLS Study Group Rating Scale）、MOS（Medical Outcomes Study ）Sleeping Scale、Self-Rating Anxiety Scale and Self-Rating Depression Scale before and after the prescription.

Official Title
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A Randomized Controlled Trial of Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Pramipexole
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PD patients (aged ≥18 years) are dialyzed with lactate-buffered glucose dialysate, using a twinbag connection system (Baxter Healthcare, Guangzhou, China). For entry , all patients are required to meet all diagnositic criteria of the International RLS Study Group (IRLSSG), to have a baseline total score >15 on the Study Group's International RLS Rating Scale (IRLS), and to have experienced RLS symptoms at least 2-3 days per week throughout the perior 3 months. Each patient should write informed consent. All patients are required to be interviewed to the frequency required by the research process. Exclusion Criteria: Patients with severe gastrointestinal illness can not tolerate oral drugs. Patients who work on a shift schedule are not allowed to participate. Women with childbearing potential are excluded for pregnancy, inadequate contraception, or current breastfeeding of a child. Patients are also excluded for current use (within 14 days before baseline) of medications that might affect RLS symptoms, e.g., levodopa, dopamine agonists or antagonists, hypnotics, lithium formulations, or antidepressants. Patients with serum ferritin ≤200 ng/ml, or Hb <110g/L, or Kt/V <1.7 are excluded. Patients with severe and unstable inflammation disease (active systemic infection, acute cardiovascular disease, active liver disease, active connective tissue disorder, ,and cancer within 1 year of radiotherapy and chemotherapy, )

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole. | Drug: Pramipexole<br>* Pramipexole will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of pramipexole is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.<br>* Other names: Dopamine Agonist;Other: placebo<br>* Placebo will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of placebo is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.<br>|
| Placebo Comparator: Control group<br>Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo. | Other: placebo<br>* Placebo will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of placebo is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in IRLSSG Score | Absolute change in IRLS sum score will be defined as a change in IRLSSG from baseline to the end of treatment phase. The scale range from 0 to 40. The higher values represent a worse outcome. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on Sleep assessment Questionnaire | The absolute change of Sleep assessment Questionnaire between baseline and the twelfth week.The scale range from 0 to 60. The higher values represent a worse outcome. | 12 weeks | 
| Effect on Quality of life (QoL) questionare | The absolute change of QoL between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome.The scale range from 36 to 162. The higher values represent a worse outcome. | 12 weeks | 
| Effect on self rating anxiety scale | The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 35 to 85. The higher values represent a worse outcome. | 12 weeks | 
| Effect on depression self rating scale | The absolute change of depression self rating between baseline and the twelfth week. The absolute change of self rating anxiety between baseline and the twelfth week. The scale range from 20 to 60. The higher values represent a worse outcome. | 12 weeks | 
| Effects on Blood pressure | The absolute change of 24-hour ambulatory blood pressure monitoring between baseline and the twelfth week. Both systolic and diastolic pressures will be assessed during the study period. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pramipexole,, Restless Leg Syndrome, Peritoneal Dialysis