Conditions: Restless Legs Syndrome
Keywords: Rotigotine Restless Legs Syndrome RLS Long-term Adolescents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: no

Brief summary:
This is a Phase 2, multicenter, open-label, single-arm, optimal dose, long-term follow-up study of monotherapy administration of rotigotine transdermal patch in adolescents with Restless Legs Syndrome (RLS). This study will assess the long-term safety and tolerability of Rotigotine treatment in adolescents with RLS.

Detailed description:
Study design was changed and an amendment was prepared accordingly.

Arms:
arm 1: Optimal dose after titration period

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)

Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Optimal dose after titration period

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)

1 patch /day

Protocol document: