Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome

Completed · Phase 2

Conditions studied: Restless Legs Syndrome

In brief

This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system. The study was conducted in adolescent subjects (13 to \<18 years of age) with idiopathic Restless Legs Syndrome (RLS).

Key facts

Study ID

NCT01495793

Run by

UCB BIOSCIENCES, Inc.

People needed

42

Starts

2011-12-01

Expected to finish

2014-05-01

Last updated by the study team

2018-04-04

Who can join

Age: 13 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject or parent/legal representative is considered reliable and capable of adhering to the protocol
• Subject is male or female, and is ≥13 and <18 years of age at Visit 2/Baseline
• Subject weighs ≥40 kg at Visit 2/Baseline
• Subject's Body Mass Index (BMI) is less than the 95th percentile for his or her age at Visit 2/Baseline
• Subject meets the diagnosis of RLS based on the proposed 2011 Revised International Restless Legs Syndrome Study Group Diagnostic Criteria
• Subject's RLS symptoms cause significant distress or impairment
• At Visit 2/Baseline, subject has a Periodic Limb Movement Index (PLMI) ≥5 during at least 1 of the 5 nights prior to Baseline as measured by the activity monitors
• At Visit 2/Baseline, subject has a score of ≥15 on the IRLS Rating Scale
• At Visit 2/Baseline, subject scores ≥4 points on the Clinical Global Impression (CGI) Item 1 assessment
• Subject receiving supplemental iron has been on a stable dose for at least 3 months prior to Visit 1/Screening Period

You may not qualify if…

• Previously participated in this study or received previous treatment with rotigotine
• Participated in another study of an investigational medicinal product (IMP) or a medical device within the last 3 months prior to Visit 1/Screening Period or is currently participating in another study of an IMP or a medical device
• Subject's RLS symptoms are restricted only to the ankles or knees
• RLS symptoms are due to renal insufficiency (uremia) or iron deficiency anemia
• Previous treatment with dopamine agonists within a period of 14 days prior to Visit 2/Baseline or L-dopa within 7 days prior to Visit 2/Baseline
• Failed to respond to previous dopaminergic therapy
• 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
• Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
• Evidence of an impulse control disorder (ICD)
• History or current symptoms of sleep apnea, narcolepsy, sleep attacks/sudden onset of sleep, or myoclonus epilepsy
• Concomitant diseases such as peripheral neuropathy, muscle fasciculation, painful legs and moving toes, fibromyalgia, rheumatoid arthritis, or sickle cell disease
• Serum ferritin level <15 ng/mL
• Subject has not attempted at least 1 non-pharmacological intervention for the management of RLS (eg, sleep hygiene, exercise)
• Prior history of psychotic episodes
• History of chronic alcohol or drug abuse within 12 months prior Screening Period
• Clinically relevant cardiac dysfunction and/or arrhythmias
• Hemoglobin level below the lower limit of normal
• Clinically relevant renal dysfunction (serum creatinine >1.5 mg/dL)
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level greater than or equal to 2 times the upper limit of normal
• History or presence of clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesion (which may be melanoma), melanoma, or a history of melanoma
• Currently receiving or has received treatment with any of the following within 28 days prior to Visit 2/Baseline: neuroleptics, antidepressants, anxiolytic drugs, opioids, monoamine oxidase (MAO) inhibitors, or sedative antihistamines
• Currently receiving treatment with any of the following: benzodiazepines, hypnotics, anticonvulsants, central alpha-adrenergic agonists, or melatonin; unless treatment is for RLS only, in which case a Wash-Out Period of at least 14 days prior to Visit 2/Baseline is required
• Currently receiving stimulant therapy for attention deficit hyperactivity disorder (ADHD); a Wash-Out Period of at least 7 days prior to Visit 2/Baseline is required
• Pregnant, nursing, or is a woman of childbearing potential who is not surgically sterile, or does not consistently use 2 combined medically acceptable methods of contraception (including at least 1 barrier method), unless not sexually active
• Unwilling to abstain from caffeine after 4pm each evening within 7 days prior to Visit 2/Baseline and for the duration of the study

Where it is running

• Sp1004 006 — Little Rock, Arkansas, United States
• Sp1004 012 — Los Angeles, California, United States
• Sp1004 009 — Orange, California, United States
• Sp1004 005 — Washington D.C., District of Columbia, United States
• Sp1004 014 — Spring Hill, Florida, United States
• Sp1004 013 — Indianapolis, Indiana, United States
• Sp1004 001 — Destrehan, Louisiana, United States
• Sp1004 015 — St Louis, Missouri, United States
• Sp1004 007 — West Seneca, New York, United States
• Sp1004 002 — Cincinnati, Ohio, United States
• Sp1004 016 — West Chester, Pennsylvania, United States
• Sp1004 003 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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