Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
- Conditions
- Restless Legs SyndromeMedDRA version: 17.1Level: PTClassification code 10058920Term: Restless legs syndromeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-004383-37-Outside-EU/EEA
- Lead Sponsor
- CB BIOSCIENCES, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 24
- 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 Restless Legs Syndrome (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
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
- 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 orthostati
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method