NCT01495793

Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

A Multicenter, Open-Label, 2-Group, Dose Escalation Study of Monotherapy Administration of Rotigotine in Pediatric Subjects With Idiopathic Restless Legs Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine	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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-12-20
• Last updated: 2018-04-04
• Results posted: 2015-07-14

Locations

12 sites across 1 country: United States