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Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Primary Purpose

Restless Legs Syndrome

Status

Terminated

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Pramipexole

placebo

About this trial

This is an interventional treatment trial for Restless Legs Syndrome focused on measuring Pramipexole,, Restless Leg Syndrome, Peritoneal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, )

Sites / Locations

Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT03817554

First Posted

January 11, 2019

Last Updated

November 28, 2021

Sponsor

Dong Jie

1. Study Identification

Unique Protocol Identification Number

NCT03817554

Brief Title

Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Terminated

Why Stopped

The recruitment of participants in the study was difficulty.

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dong Jie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

Keywords

Pramipexole,, Restless Leg Syndrome, Peritoneal Dialysis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Pramipexole

Other Intervention Name(s)

Dopamine Agonist

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Absolute change in IRLSSG Score

Description

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

Secondary Outcome Measure Information:

Title

Effect on Sleep assessment Questionnaire

Description

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

Title

Effect on Quality of life (QoL) questionare

Description

Time Frame

12 weeks

Title

Effect on self rating anxiety scale

Description

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

Title

Effect on depression self rating scale

Description

Time Frame

12 weeks

Title

Effects on Blood pressure

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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, )

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie Dong

Organizational Affiliation

Peking Universiy First Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Peking University First Hospital

City

Beijing

ZIP/Postal Code

100034

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32075834

Citation

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.

Results Reference

derived

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Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

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