Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

NCT03817554 | Terminated Phase 4 DMC FDA Drug

• 1 other identifier: pramipexole
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Restless Legs Syndrome

Keywords

Pramipexole,; Restless Leg Syndrome; Peritoneal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Effect on Sleep assessment Questionnaire

  12 weeks

• Effect on Quality of life (QoL) questionare

  12 weeks

• Effect on self rating anxiety scale

  12 weeks

• Effect on depression self rating scale

  12 weeks

• Effects on Blood pressure

  12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Pramipexole; Other: placebo

Control group

PLACEBO COMPARATOR

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

Other: placebo

Interventions

Pramipexole DRUG

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.

Also known as: Dopamine Agonist

Treatment group

placebo OTHER

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.

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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, )

Sponsors & Collaborators

• Dong Jie: lead

Study Sites (1)

Peking University First Hospital

Beijing, 100034, China

Location

Related Publications (1)

• 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.

  PMID: 32075834 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole; Dopamine Agonists

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Jie Dong

  Peking Universiy First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 25, 2019
• Study Start: July 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: December 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)