Status:
TERMINATED
Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients
Lead Sponsor:
Dong Jie
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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
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 we...
Eligibility Criteria
Inclusion
- 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
- 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, )
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03817554
Start Date
July 1 2019
End Date
August 31 2020
Last Update
December 9 2021
Active Locations (1)
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1
Peking University First Hospital
Beijing, China, 100034