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

NCT ID: NCT03728933

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2022-07-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

2 milligram/24 hours rotigotine

Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 2 mg/24 h rotigotine, which is the assigned dose level throughout the 12-week Maintenance Period.

Group Type: EXPERIMENTAL

Rotigotine 1 milligram/24 hours

Intervention Type: DRUG

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).

Rotigotine 2 milligram/24 hours

Intervention Type: DRUG

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).

3 milligram/24 hours rotigotine

Subjects randomized to this arm will be initiated on 1 milligram (mg)/24 hours (h) rotigotine and up-titrated to a maximum of 3 mg/24 h rotigotine (1 mg/24 h patch + 2 mg/24 patch at the same time), which is the assigned dose level throughout the 12-week Maintenance Period.

Group Type: EXPERIMENTAL

Rotigotine 1 milligram/24 hours

Intervention Type: DRUG

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).

Rotigotine 2 milligram/24 hours

Intervention Type: DRUG

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).

Placebo

Subjects randomized to this arm will receive matching placebo patches to maintain the blinding.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Placebo

Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable

Intervention Type: DRUG

Other Intervention Names

Neupro; Neupro

Eligibility Criteria

Inclusion Criteria

• Subject is male or female, and is >=13 and <18 years of age at Baseline
• Subject's Restless Legs Syndrome (RLS) symptoms cause significant daytime symptoms or significant distress or impairment in social, occupational, educational, or other important areas of functioning by the impact on sleep, energy/vitality, daily activities, behavior, cognition or mood
• At Baseline, subject has a score of >=15 on the International Restless Legs Rating Scale (IRLS) (indicating moderate-to-severe RLS)
• At Baseline, subject scores >=4 points on the Clinical Global Impressions (CGI) Item 1 assessment (indicating at least moderately ill)
• Subjects who are receiving supplemental iron have been on a stable dose for at least 1 month prior to Screening
• Female subjects must be surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is an acceptable method. Subjects must agree to use adequate contraception during the study and for 4 weeks after their final dose of study medication.

Exclusion Criteria

• Subject has a serum ferritin level below the lower limit of normal at Visit 1/Screening
• Subject has a hemoglobin level below the lower limit of normal at Visit 1/Screening
• Subject has had previous treatment with dopamine agonists or L-dopa within 7 days prior to Visit 2/Baseline
• Subject has any medical or psychiatric condition, which in the opinion of the investigator, would jeopardize or compromise the subject's well-being or ability to participate in this study
• Subject is pregnant or nursing
• Subject is not willing to abstain from caffeine after 4 pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study
• At Visit 1/Screening, subject has symptomatic orthostatic hypotension with a decrease of blood pressure (BP) from supine to standing position of >=20 mmHg in systolic blood pressure (SBP) or of >=10 mmHg in diastolic
• Subject has secondary Restless Legs Syndrome (RLS) (eg, due to renal insufficiency [uremia], iron deficiency, or rheumatoid arthritis)
• Subject has a lifetime history of suicide attempts (including actual attempt, interrupted attempt, or aborted attempt), or had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening (Visit 1)
• Subject is taking a prohibited concomitant medication. Prohibited concomitant medication must have been discontinued at least 2 weeks prior to Screening (Visit 1)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273

Locations

Sp1006 101

Culver City, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SP1006

Identifier Type: -

Identifier Source: org_study_id