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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01823770
Other study ID # 8917
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 26, 2012
Est. completion date June 23, 2017

Study information

Verified date May 2018
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Intervention

Drug:
Rotigotine
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).
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

Locations

Country Name City State
France UH Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other change from baseline score of International RLS severity scale ((IRLS), RLSQoL, CGI)) at 35+/-3 days Questionnaires on Epworth, IRLSQ, RLS QoL, CGI V0(Day -10± 3V1 (Day 0±3), V2(Day 14±3), V3(Day 21±3), V4(Day 35± 3)
Other change from baseline "total sleep time" at 35 +/-3 days Nocturnal polysomnography (PSG) At the first visit (day 0) and the forth visit (day 35 +/- 3)
Other change from baseline cytokine level at 35+/-3days Fasting morning blood sample At the first visit (day 0) and the forth visit (day 35 +/- 3)
Other change from baseline % sleep stage at 35+/-3 days Nocturnal polysomnography (PSG) At the first visit (day 0) and the forth visit (day 35 +/- 3)
Other change from baseline Lipid level at 35+/-3 days Fasting morning blood sample At the first visit (day 0) and the forth visit (day 35 +/- 3)
Other change from baseline glucid level at 35+/-3days Fasting morning blood sample At the first visit (day 0) and the forth visit (day 35 +/- 3)
Primary Percentages of non-dippers(defined as <10% drop in BP during sleep)at 35+/-3 days Percentages of non-dippers is defined as <10% drop in blood pressure (BP) during sleep (24h ambulatory BP monitoring). 35 +/- 3 day
Secondary Digital pulse amplitude measured by reactive hyperhemia with finger plethysmographic methodology Fasting morning peripheral arterial tonometry (PAT) day 35 +/- 3
Secondary PLMS and PLMS-microarousal indexes Nocturnal polysomnography (PSG) day 35 +/- 3
Secondary Amplitude of PLMS-related HR responses Nocturnal polysomnography (PSG) day 35 +/- 3
See also
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Terminated NCT02826681 - Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia Phase 2
Completed NCT02397057 - Placebo-Controlled Study to Investigate the Efficacy & Safety of Injectafer in the Treatment of RLS Phase 3
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Completed NCT00363857 - A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome Phase 3