Conditions: Restless Legs Syndrome
Keywords: Rotigotine Restless Legs Syndrome RLS Children Adolescents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief summary:
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system. The study was conducted in adolescent subjects (13 to \<18 years of age) with idiopathic Restless Legs Syndrome (RLS).

Detailed description:

Arms:
arm 1: In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.

Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine transdermal patch:

Dose (size): 0.5 mg/24 h (2.5 cm\^2)- 1 mg/24 h (5 cm\^2)- 2 mg/24 h (10 cm\^2)- 3 mg/24 h (15 cm\^2) The patch has to be applied continuously for 24h. After 24h, the patch has to be removed and a new one applied.

Protocol document: