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

NCT03992196 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-30

Study results available
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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

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).

Sponsors & Collaborators

  • UCB Biopharma SRL

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-12-03
Primary Completion
2022-09-01
Completion
2022-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03992196 on ClinicalTrials.gov