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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
21
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.
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.
Peking University First Hospital
Beijing, China
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.
Time frame: 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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