EUCTR2006-002139-26-DE进行中（未招募）不适用
An open label, repeat dose, dose escalation study conducted in RLS patients to characterize pharmacokinetics and food effect of ropinirole controlled release for RLS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with a diagnosis of RLS using the RLS Diagnostic Clinical Interview and
- •the International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic
- •Criteria at pre-study screening.
- •Patients between 18 and 65 years of age inclusive.
- •Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg.
- •Patients must have given written informed consent prior to admission to the study.
- •Normal systolic (100-140mmHg) and diastolic (<90 mmHg) blood pressure (supine)
- •at pre-study screening and prior to the first dose of study medication on Day 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who smoke = 20 cigarettes per day or patients who smoke less than 20
- •cigarettes per day but will not maintain a constant smoking habit for the duration of
- •Patients with a history of postural hypotension or faints.
- •Patients with signs of secondary RLS (e.g., end stage renal disease, iron deficiency
- •anaemia or pregnancy at pre-study screening).
- •Patients with a serum ferritin level of <10 mcg/L (ng/mL) that has not resolved prior
- •to the first dose of study medication on Day 1.
- •Patients who suffer from a primary sleep disorder other than RLS that may
- •significantly affect the symptoms of RLS (e.g., narcolepsy, sleep terror disorder,
- •sleepwalking disorder, breathing-related sleep disorder).
- •Patients diagnosed with movement disorders (e.g., Parkinson’s disease, dyskinesias,
- •and dystonias).
- •Patients who have medical conditions that are clinically significant or have unstable
- •medical conditions that present a safety concern. These may include, but are not
- •limited to, the following disorders: diabetes, symptomatic orthostatic hypotension,
- •severe cardiovascular disease, hepatic or renal failure, pleuropulmonary fibrosis,
- •history of psychotic illness, compulsive behaviour.
- •Definite or suspected personal history or family history of adverse reactions or
- •hypersensitivity to the study drug or to drugs with a similar chemical structure.
- •Patients having a clinically significant abnormal laboratory value, ECG, or physical
- •examination finding not resolved prior to the first dose of study medication on Day
- •1. Abnormal 12-lead ECG findings include, but are not limited to, the following:
- •myocardial ischemia, clinically significant conduction abnormalities, clinically
- •significant arrhythmias or QTc > 450 msec.
- •Patients with an orthostatic blood pressure drop of =10mmHg in the diastolic blood
- •pressure or =20mmHg in the systolic blood pressure at pre-study screening.
- •Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT)
- •and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin,
- •cimetidine, fluvoxamine, HRT) or induce CYP1A2 (e.g., tobacco, omeprazole)
- •within 7 days prior to prior to the first dose of study medication on Day 1. Patients
- •already on these agents may be enrolled, but must remain on stable doses of the
- •agents from 7 days prior to the first dose of study medication on Day 1 through to the follow-up visit at the end of the study.
- •Patients who have exhibited intolerance to ropinirole or any other dopamine agonist,
- •levodopa/carbidopa or to dopamine antagonists.
- •Participation in any clinical drug or device trial within 90 days prior to the first dose
- •of study medication on Day 1.
- •Blood donation or blood loss of >200mL less than 90 days before the present study.
- •Patients who, in the opinion of the investigator, would be non-compliant with the
- •visit schedules or other study procedures.
- •Women who have a positive pregnancy test or who are breast-feeding.
- •Women of child-bearing potential who are not practising a clinically accepted
- •method of contraception such as oral contraception, surgical sterilization, Intrauterine
- •device (IUD), diaphragm in conjunction with spermicidal foam, condom on
- •the male partner in conjunction with spermicidal foam or systemic contraception
- •(e.g., Norplant). Male patients with female partners must also practice a clinically
- •accepted method of contraception.
- •Positive pre-study screening result for hepatitis B surface antigen, hepatitis C
- •antibody or HIV-1/2 antibodies.
研究者
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