Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Dong Jie

Status and phase: Terminated; Phase 4

Conditions: Restless Legs Syndrome

Treatments: Drug: Pramipexole; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03817554

pramipexole

Details and patient eligibility

About

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

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. PD patients (aged ≥18 years) are dialyzed with lactate-buffered glucose dialysate, using a twinbag connection system (Baxter Healthcare, Guangzhou, China).
2. 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.
3. Each patient should write informed consent.
4. All patients are required to be interviewed to the frequency required by the research process.

Exclusion criteria

1. Patients with severe gastrointestinal illness can not tolerate oral drugs.
2. Patients who work on a shift schedule are not allowed to participate.
3. Women with childbearing potential are excluded for pregnancy, inadequate contraception, or current breastfeeding of a child.
4. 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.
5. Patients with serum ferritin ≤200 ng/ml, or Hb <110g/L, or Kt/V <1.7 are excluded.
6. 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, )

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.

Treatment:

Drug: Pramipexole

Other: placebo

Control group

Placebo Comparator group

Description:

Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo.

Treatment:

Other: placebo