Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

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

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

Study Overview

• Status: Terminated
• Conditions: Restless Legs Syndrome
• Intervention / Treatment: Drug: Pramipexole; Other: placebo

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 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
• Enrollment (Actual): 21
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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, )

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group; Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole.	Drug: Pramipexole; 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.; Other Names: Dopamine Agonist; Other: placebo; 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.
PLACEBO_COMPARATOR: Control group; Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo.	Other: placebo; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dong Jie

Publications and helpful links

General Publications

• Ma TT, Yang Z, Zhu S, Zhao JH, Li Y, Sun FY, Zhao N, Xiong ZY, Xiong ZB, Dong J. Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial. BMJ Open. 2020 Feb 18;10(2):e033815. doi: 10.1136/bmjopen-2019-033815.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: January 11, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (ACTUAL): January 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: November 28, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; Restless Leg Syndrome; Pramipexole,
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Antioxidants; Sympathomimetics; Antiparkinson Agents; Anti-Dyskinesia Agents; Dopamine; Pramipexole; Dopamine Agonists
• Other Study ID Numbers: pramipexole

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes