Pramipexole for Restless Leg Syndrome in Peritoneal Dialysis Patients

NCT ID: NCT03817554

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-08-31

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.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Pramipexole

Intervention Type: 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.

placebo

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Dopamine Agonist

Eligibility Criteria

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, )

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dong Jie

OTHER

Sponsor Role: lead

Responsible Party

Dong Jie

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jie Dong

Role: STUDY_DIRECTOR

Peking Universiy First Hospital

Locations

Peking University First Hospital

Beijing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32075834 (View on PubMed)

Other Identifiers

pramipexole

Identifier Type: -

Identifier Source: org_study_id