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

UCB

Status and phase

Completed

Phase 2

Conditions

Restless Legs Syndrome

Treatments

Drug: Rotigotine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01495793

SP1004

2014-004383-37 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

42 patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Pursues shift work or performs other continuous non-disease-related life conditions, which do not allow regular sleep at night
Subject has a QT correction (QTc) interval of ≥500 ms at Visit 1/Screening Period or Visit 2/Baseline. Bazett's correction method must be used for the correction of the QT interval
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 blood pressure (DBP) taken from the 5 minute supine and 1 and/or 3 minute standing measurements
A known hypersensitivity to any of the components of the study medication, such as a history of significant skin hypersensitivity to adhesives, known hypersensitive