Clinical trial NCT03728933: A Study of Rotigotine Patch in Adolescent Subjects With Restless Legs Syndrome of Unknown Cause
Official title: A Remote, Double-Blind, Randomized, Placebo-Controlled Study of Rotigotine Transdermal System in Adolescent Subjects With Idiopathic Restless Legs Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Restless Legs Syndrome
Keywords: RLS
Rotigotine
Neupro
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 23
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change From Baseline to the End of the Maintenance Period in International Restless Legs Rating Scale (IRLS) Sum Score
timeFrame: From Baseline to the end of the Maintenance Period (Day 106)
measure: Change From Baseline in Clinical Global Impressions (CGI) Item 1 to the End of the Maintenance Period
timeFrame: From Baseline to the end of the Maintenance Period (Day 106)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: From Baseline to Safety Follow-Up (up to Week 20)
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawals
timeFrame: From Baseline to Safety Follow-Up (up to Week 20)
Secondary outcomes:
measure: Change From Baseline in Restless Legs-6 Rating Scales (RLS-6) to the End of the Maintenance Period
timeFrame: From Baseline to the end of the Maintenance Period (Day 106)
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Sp1006 101
state: California
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: STUDY_DIRECTOR
References: