Restless legs syndrome
Conditions
Interventions
Pramipexole Group:Pramipexole + Grisugabalin placebo
Grisugabalin Group:Grisugabalin + pramipexole placebo
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Primary RLS patients aged 18 to 75 years old (including the boundary value). 2.Screen for a history of RLS symptoms lasting at least 15 consecutive days within the previous month. 3.During the screening period, there were at least 2 days within 7 days when RLS symptoms were recorded. 4.During the screening process, the International RLS Rating Scale (IRLS) score was >= 15 points. 5.Exclude those who did not receive dopamine agonists and/or gabapentin, pregabalin and/or other RLS treatments (opioids, benzodiazepines, etc.) within the previous 2 weeks. 6.During the screening process, the BMI value should be within the range of 18.0 to 35.0 kg/m^2. 7.During the research period, they were willing to maintain a good schedule and lifestyle. 8.If the participants are women with reproductive capacity, they must agree to use clinically approved contraceptive methods after completing the study. 9.Be able to understand the procedures and methods of this trial and voluntarily sign the ICF.
Exclusion criteria
Exclusion criteria: 1.Sleep disorders that may significantly affect the RLS assessment (such as sleep apnea); 2.Neurological diseases or movement disorders (such as diabetic neuropathy, stroke, Parkinson's disease, multiple sclerosis, movement disorders and dystonia); 3.Significantly abnormal laboratory results (biochemical & hematological), electrocardiogram (ECG) results, or physical examination results; 4.Pregnant women or lactating women, as well as women of childbearing age who have not adopted an acceptable form of birth control; 5.Patients with renal insufficiency; 6.Other researchers determined that there were cases where individuals were not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the 12-week treatment point, the change in the International Restless Legs Syndrome (IRLS) rating scale score compared to the baseline period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| AE, TEAE, Laboratory tests.;The proportion of participants who showed "considerable improvement" or "very significant improvement" on the Clinical Global Impression Scale (CGI) after 12 weeks of treatment.;The changes in the Mini-Mental State Examination (MMSE) scale compared to the baseline period at 12 weeks of treatment.;The change in the Restless Legs Syndrome Quality of Life Score (RLSQoL) from the baseline period after 12 weeks of treatment.;The changes in the Hamilton Anxiety Depression Scale (HAMA & HAMD) scores compared to the baseline period.; | — |
Countries
China
Contacts
Public ContactWu Yuncheng
Shanghai General Hospital
Outcome results
None listed