Restless Legs SyndromeClin-RLSNCT05044520
Clinical Features Associated With Restless Legs Syndrome.
An observational study of Restless Legs Syndrome, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Legs Syndrome
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RLS who are members of the RLS patient association
Who may be able to join
- 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
Who cannot join
- Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Sofiene Chenini, MD, 467332237 ext. 33, sofienechenini@hotmail.com
Yves DAUVILLIERS, MD PhD, 467337478 ext. 33, y-dauvilliers@chu-montpellier.fr
About this study
Official title: Clinical Features Associated With Restless Legs Syndrome : Clin-RLS
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.
Read the detailed 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.
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless legs syndrome, Augmentation syndrome, Dopamine agonists, Alpha 2 delta ligands, Opiates
- Medical subject headings
- Restless Legs Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Four minutes
Secondary outcomes (7)
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
Measured: two minutes
Augmentation Severity Rating Scale (ASRS)
Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms
Measured: two minutes
Epworth severity scale (ESS)
Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness
Measured: two minutes
Insomnia Severity Index (ISI)
Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia
Measured: two minutes
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
Measured: Six minute
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
Measured: One minute
Homemade questionnaire assessing the falling risk
Homemade questionnaire assessing the falling risk. ranging from 0 to 6, with higher scores indicating worse falling risk
Measured: Five minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves DAUVILLIERS, MD PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044520
- Sponsor's protocol ID
- RECHMPL21_0535
- Acronym
- Clin-RLS
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features Associated With Restless Legs Syndrome : Clin-RLS
- ClinicalTrials.gov ID
- NCT05044520
- Acronym / sponsor ID
- Clin-RLS / RECHMPL21_0535
- Conditions
- Restless Legs Syndrome
- Keywords
- Restless legs syndrome, Augmentation syndrome, Dopamine agonists, Alpha 2 delta ligands, Opiates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RLS who are members of the RLS patient association
Key inclusion criteria (7 listed)
- Adults subjects
- Restless legs syndrome diagnosis
- Member of the restless legs syndrome association
- French speaking
- Able to understand the study
Key exclusion criteria (1 listed)
- Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
International restless legs syndrome study group rating scale (IRLS)
Time frame: Four minutes
International restless legs syndrome study group rating scale (IRLS). ranging from 0 to 40, with higher scores indicating worse restless legs symptoms
7 secondary outcomes
Restless Legs Syndrome-6 Scale (RLS-6)
Time frame: two minutes
Augmentation Severity Rating Scale (ASRS)
Time frame: two minutes
Epworth severity scale (ESS)
Time frame: two minutes
Insomnia Severity Index (ISI)
Time frame: two minutes
Beck's Depression Inventory - II (BDI-II)
Time frame: Six minute
European Quality of life - 5 dimensions (EQ-5D)
Time frame: One minute
Homemade questionnaire assessing the falling risk
Time frame: Five minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves DAUVILLIERS, MD PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofiene Chenini, MD (467332237 ext. 33, sofienechenini@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International restless legs syndrome study group rating scale (IRLS) (time frame: Four minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.