NCT03992196

A Follow-up Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome

A Remote, 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: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety, tolerability and the long-term efficacy of rotigotine treatment in adolescents with idiopathic Restless Legs Syndrome (RLS).

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine 1 mg/24 h	Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 mg/24 h (5 cm\^2 patch size).
DRUG	Rotigotine 2 mg/24 h	Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 mg/24 h (10 cm\^2 patch size).
DRUG	Rotigotine 3 mg/24 h	Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 3 mg/24 h (15 cm\^2 patch size).

Timeline

• Start date: 2019-12-03
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-06-20
• Last updated: 2023-10-30
• Results posted: 2023-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study