NCT01498120

Long-Term Follow-Up Study for Safety, Efficacy and Tolerability of Rotigotine in Adolescents With Restless Legs Syndrome

An Open-Label, Long-Term, Follow-Up Study To Determine The Safety, Tolerability, and Efficacy of Rotigotine Transdermal System As Monotherapy in Adolescents With Restless Legs Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine	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

Timeline

• Start date: 2011-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2011-12-23
• Last updated: 2017-08-01
• Results posted: 2016-09-21

Locations

5 sites across 1 country: United States