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

NCT03728933 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-10-26

Study results available
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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

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

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2022-07-25
Completion
2022-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03728933 on ClinicalTrials.gov