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

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma S.P.R.L.
• Treatments: Rotigotine

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)

• If subject is receiving supplemental iron, subject has been on a stable dose for at least 3 months 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 <50 ng/mL 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