Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome (NCT01823770) | Clinical Trial Compass
CompletedPhase 4
Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome
France130 participantsStarted 2012-11-26
Plain-language summary
Several studies report association between restless legs syndrome (RLS), HTA and cardiovascular diseases .
The mechanisms involved in this relationship remained unknown, but several evidences favor the role of periodic limb movements in sleep (PLMS), patterns frequently associated with RLS. Sympathetic overactivity is associated with PLMS with increased pulse rate and blood pressure coincident with PLMS. PLMS-related repetitive nocturnal blood pressure fluctuations could contribute to the risk of high blood pressure, heart disease, and stroke in patients with RLS, especially in the elderly. Several studies already reported that dopaminergic agonists reduce the severity of RLS and the PLMS index.
Do dopaminergic agonists reduce the risk of cardiovascular diseases and associated autonomic dysfunctions in patients with RLS ?
Nocturnal BP (blood pressure) decline has major clinical implications, and the loss of normal reduction in BP during sleep is associated with high risk of cardiovascular morbidity and mortality.
The main aim of this study was to evaluate the impact of rotigotine patch treatment on validated cardiovascular risk factors ambulatory BP during night, day and night-to-day ratio, and endothelial function in patients with idiopathic RLS compared to placebo.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
. Subject understands the investigational nature of the study and is willing and able to comply with the study requirements. Subject is willing to accept that he/she might be treated with placebo during the Treatment Period.
. Subject is able to apply/remove the study patches correctly.
. Subject is male or female, and is ≥18 and ≤80 years of age.
. Subject has a body mass index (BMI) of ≥18kg/m2 and ≤35kg/m2.
. Subject has ferritin concentration of ≥50ng/mL at Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentages of non-dippers(defined as <10% drop in BP during sleep)at 35+/-3 days
. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
. Subject understands the investigational nature of the study and is willing and able to comply with the study requirements.
Exclusion criteria
. Subject has RLS associated with previous or concomitant therapy with dopamine D2 receptor antagonists, butyrophenones, metoclopramide, atypical antipsychotics (eg, olanzapine), antidepressants, mianserine, or lithium or H2-blockers (eg, cimetidine).
. Subject has a history of any sleep disorder other than RLS including a severe obstructive sleep apnea syndrome (Apnea hypopnea index \> 30/h) not treated by a controlled Continuous Positive Airway Therapy (CPAP) for at least 1 month prior to Screening, or has narcolepsy or other hypersomnia.
. Subject has clinically relevant polyneuropathy which cannot be clearly differentiated from RLS symptoms in the opinion of the investigator.
. Subject has additional clinically relevant concomitant diseases, such as attention deficit hyperactivity disorder, painful legs, and moving toes.
. Subject has other central nervous system diseases, such as Parkinson's disease, dementia, progressive supranuclear paresis, multisystem atrophy, Huntington's chorea, amyotrophic lateral sclerosis, or Alzheimer's disease.
. Subject has evidence of an impulse control disorder (Visit 1) as assessed by the Minnesota Impulsive Disorders Interview. If a subject has 1 or more positive modules on the mMIDI, he/she must be referred for a structured clinical interview, such as the Structured Clinical Interview for DSM-IV Axis 2 Personality Disorders (SCID-II) or another applicable structured interview for the diagnosis of ICDs.
. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months.
. Subject has a prior history of psychotic episodes.