Status:
COMPLETED
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
Lead Sponsor:
UCB BIOSCIENCES, Inc.
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
13-17 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01495793
Start Date
December 1 2011
End Date
May 1 2014
Last Update
April 4 2018
Active Locations (12)
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1
Sp1004 006
Little Rock, Arkansas, United States
2
Sp1004 012
Los Angeles, California, United States
3
Sp1004 009
Orange, California, United States
4
Sp1004 005
Washington D.C., District of Columbia, United States