Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome

PHASE4CompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

November 26, 2012

Primary Completion Date

July 4, 2016

Study Completion Date

June 23, 2017

Conditions
Restless Legs Syndrome (RLS)
Interventions
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).

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

Trial Locations (1)

34295

UH Montpellier, Montpellier

All Listed Sponsors
lead

University Hospital, Montpellier

OTHER

NCT01823770 - Effect of Rotigotine Patch Treatment on Cardiovascular Markers in Idiopathic Restless Legs Syndrome | Biotech Hunter | Biotech Hunter