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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05044520
Other study ID # RECHMPL21_0535
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 1, 2027

Study information

Verified date September 2021
Source University Hospital, Montpellier
Contact Sofiene Chenini, MD
Phone 467332237
Email sofienechenini@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.


Description:

In this study, the investigators want to study the clinical course of RLS in a population of RLS patients who are members of the RLS patient association, taking into account clinical and biological factors as well as the treatments taken for RLS.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date September 1, 2027
Est. primary completion date September 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Adults subjects - Restless legs syndrome diagnosis - Member of the restless legs syndrome association - French speaking - Able to understand the study - Signed written informed consent - Affiliated to social security Exclusion criteria: - Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary International restless legs syndrome study group rating scale (IRLS) International restless legs syndrome study group rating scale (IRLS). ranging from 0 to 40, with higher scores indicating worse restless legs symptoms Four minutes
Secondary Restless Legs Syndrome-6 Scale (RLS-6) Restless Legs Syndrome-6 Scale (RLS-6)symptoms after a surgical procedure under general or locoregional anesthesia. ranging from 0 to 60, with higher scores indicating worse restless legs symptoms two minutes
Secondary Augmentation Severity Rating Scale (ASRS) Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms two minutes
Secondary Epworth severity scale (ESS) Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness two minutes
Secondary Insomnia Severity Index (ISI) Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia two minutes
Secondary Beck's Depression Inventory - II (BDI-II) Beck's Depression Inventory - II (BDI-II). ranging from 0 to 63, with higher scores indicating worse depressive symptoms Six minute
Secondary European Quality of life - 5 dimensions (EQ-5D) European Quality of life - 5 dimensions (EQ-5D). ranging from 0 to 100. Higher scores indicate better health condition One minute
Secondary Homemade questionnaire assessing the falling risk Homemade questionnaire assessing the falling risk. ranging from 0 to 6, with higher scores indicating worse falling risk Five minutes
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