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The recruitment of participants in the study was difficulty.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Peritoneal dialysis patients diagnosed with restless legs syndrome will receive pramipexole. |
|
| Control group | Placebo Comparator | Peritoneal dialysis patients diagnosed with restless legs syndrome will receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Dong | Peking Universiy First Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | 100034 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32075834 | Derived | 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. |
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| ID | Term |
|---|---|
| D012148 | Restless Legs Syndrome |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| D018491 | Dopamine Agonists |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| 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. |
|
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 |
| D020447 |
| Parasomnias |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015259 | Dopamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |