Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome
|ClinicalTrials.gov Identifier: NCT01823770|
Recruitment Status : Unknown
Verified March 2013 by University Hospital, Montpellier.
Recruitment status was: Recruiting
First Posted : April 4, 2013
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome (RLS)||Drug: Rotigotine Drug: Placebo patchs||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome : a Pilot Randomized, Placebo-controlled Study|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||December 2015|
Active Comparator: Rotigotine
Patients randomized to rotigotine who will be treated with rotigotine patchs
Subjects randomized to rotigotine will start treatment with a rotigotine dose of 1mg/24h for 1 week. The dose can be increased weekly until either the optimal or the maximal dose of 3mg/24h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1mg/24h every other day until complete withdrawal (Taper period).
Other Name: Rotigotine patchs
Placebo Comparator: Placebo
Patients randomized on the placebo group who will be treated with placebo patchs
Drug: Placebo patchs
Subject randomized on the placebo group will be treated with placebo patchs, following the same modalities and study periods that the rotigotine arm
No Intervention: Control group
Volunteers matched on sex, age and BMI with RLS patients who will not receive treatment(no treatment)
- Percentages of non-dippers(defined as <10% drop in BP during sleep)at 35+/-3 days [ Time Frame: 35 +/- 3 day ]Percentages of non-dippers is defined as <10% drop in blood pressure (BP) during sleep (24h ambulatory BP monitoring).
- Digital pulse amplitude measured by reactive hyperhemia with finger plethysmographic methodology [ Time Frame: day 35 +/- 3 ]Fasting morning peripheral arterial tonometry (PAT)
- PLMS and PLMS-microarousal indexes [ Time Frame: day 35 +/- 3 ]Nocturnal polysomnography (PSG)
- Amplitude of PLMS-related HR responses [ Time Frame: day 35 +/- 3 ]Nocturnal polysomnography (PSG)
- change from baseline score of International RLS severity scale ((IRLS), RLSQoL, CGI)) at 35+/-3 days [ Time Frame: V0(Day -10± 3V1 (Day 0±3), V2(Day 14±3), V3(Day 21±3), V4(Day 35± 3) ]Questionnaires on Epworth, IRLSQ, RLS QoL, CGI
- change from baseline "total sleep time" at 35 +/-3 days [ Time Frame: At the first visit (day 0) and the forth visit (day 35 +/- 3) ]Nocturnal polysomnography (PSG)
- change from baseline cytokine level at 35+/-3days [ Time Frame: At the first visit (day 0) and the forth visit (day 35 +/- 3) ]Fasting morning blood sample
- change from baseline % sleep stage at 35+/-3 days [ Time Frame: At the first visit (day 0) and the forth visit (day 35 +/- 3) ]Nocturnal polysomnography (PSG)
- change from baseline Lipid level at 35+/-3 days [ Time Frame: At the first visit (day 0) and the forth visit (day 35 +/- 3) ]Fasting morning blood sample
- change from baseline glucid level at 35+/-3days [ Time Frame: At the first visit (day 0) and the forth visit (day 35 +/- 3) ]Fasting morning blood sample
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823770
|Contact: Yves Dauvillers, PU PH||+33 4 67 33 72 firstname.lastname@example.org|
|Montpellier, France, 34295|
|Contact: Claire Chauveton +33 467330924 email@example.com|
|Principal Investigator: Yves Dauvilliers, PU PH|
|Sub-Investigator: Valérie Cochen de Cock, PH|
|Sub-Investigator: Bertrand Carlander, PH|
|Principal Investigator:||Yves Dauvilliers, PU PH||UH Montpellier|