Clinical Features Associated With Restless Legs Syndrome.

NCT ID: NCT05044520

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2027-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Restless Legs Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yves DAUVILLIERS, MD PhD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uhmontpellier

Montpellier, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sofiene Chenini, MD

Role: CONTACT

467332237 ext. 33

Yves DAUVILLIERS, MD PhD

Role: CONTACT

467337478 ext. 33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sofiene Chenini, MD

Role: primary

467332237 ext. 33

Yves DAUVILLIERS, MD PhD

Role: backup

467337478 ext. 33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHMPL21_0535

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.