NCT03728933

A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause

A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (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 demonstrate the efficacy of rotigotine against placebo in adolescent subjects with idiopathic Restless Legs Syndrome (RLS) over a 12-week maintenance period and to investigate the safety and tolerability of rotigotine in adolescent subjects with idiopathic RLS.

Conditions

• Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	Rotigotine 1 milligram/24 hours	Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm\^2) patch size).
DRUG	Rotigotine 2 milligram/24 hours	Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm\^2) patch size).
DRUG	Placebo	Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable

Timeline

• Start date: 2018-12-20
• Primary completion: 2022-07-25
• Completion: 2022-07-25
• First posted: 2018-11-02
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study