EUCTR2006-006209-94-DE进行中（未招募）不适用
An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
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
- •1. Male or female patients aged between 30 and 85 years of age inclusive at
- •2. Body mass index of 18 to 32 kg/m2, with a body weight of at least 50 kg.
- •3. Diagnosis of idiopathic Parkinson’s Disease graded according to modified Hoehn
- •& Yahr Stage I-III (Appendix 4).
- •4. Patients must have provided written informed consent prior to performing any
- •Screening assessments, including any washout of concomitant medications in
- •preparation for this study.
- •5. QTc interval of < 450ms at screening (or QTc < 480ms in patients with Bundle
- •Branch Block).
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who have an abnormality on physical examination. A patient with clinical
- •abnormality may be included only if the Investigator considers that the abnormality
- •will not introduce additional risk factors and will not interfere with the study
- •procedures.
- •2. Patients who, in the opinion of the Investigator, have medical conditions which could present a safety concern. These may include, but are not limited to, the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, hepatic or renal failure, pleuropulmonary fibrosis, significant and/or uncontrolled psychiatric, haematological, endocrinological, neurological (other than Parkinson’s disease), or cardiovascular disease (including myocardial infarction, unstable angina pectoris, cardiac arrhythmias, cerebrovascular accident (CVA), or patients who are known to have malignancy, are being treated for malignancy or have had treatment for malignancy within the last year (other than basal cell cancer).
- •3. Patients having a clinically significant abnormal laboratory value, ECG, or physical
- •examination findings not resolved by the time of the baseline examinations.
- •Abnormal 12-lead ECG findings include, but are not limited to, the following:
- •myocardial ischemia, clinically significant conduction abnormalities, or clinically
- •significant arrhythmias.
- •4. Positive result for Hepatitis B surface antigen, Hepatitis C antibody or Human
- •Immunodeficiency Virus (HIV) antibody at screening.
- •5. Positive alcohol test result and / or urine test for undeclared drugs at screening.
- •6. Recent history of moderate to severe dizziness, syncope, or orthostatic hypotension,
- •defined as a fall in blood pressure, after rising from the supine to erect posture, of >
- •30 mmHg for systolic pressure and > 20 mmHg for diastolic pressure.
- •7. Significant sleep disorder or Epworth Sleep Score (Appendix 5) = 9 at screening.
- •8. Patients with a lying/sitting diastolic blood pressure =110mmHg or =50mmHg or a
- •systolic blood pressure =180mmHg or =90mmHg at the Screening or Baseline Visit.
- •9. History of any dopaminergic treatment (other than ropinirole IR and L-dopa) within
- •2 weeks prior to first dose.
- •Patients on dopaminergic agonists other than ropinirole IR and L-dopa may be
- •enrolled if the agent is stopped for a 2-week wash-out period prior to first dose.
- •Patients taking ropinirole IR or L-dopa may switch to ropinirole PR/CR 2mg on
- •study day 1, providing they have first followed the manufacturer’s down
- •titration guidelines.
- •Patients taking ropinirole IR > 4mg/day must be down-titrated according to the
- •manufacturer’s guidelines prior to study day 1.
- •Patients taking ropinirole IR or L-dopa must have been on a stable dose for at
- •least 4 weeks prior to screening; doses of ropinirole IR or L-dopa may need to
- •be adjusted prior to or during the study.
- •Patients on selegiline, amantadine, or anticholinergics may be enrolled but must
- •have been on a stable dose for at least one month prior to study enrolment and
- •must remain on their current dose throughout the treatment phase of the study.
- •10. Withdrawal, introduction, or change in dose of hormone replacement therapy and/or any drug known to substantially inhibit CYP1A2 (e.g., cimetidine, ciprofloxacin,
- •fluvoxamine) or induce CYP1A2 (e.g., tobacco, or omeprazole) within 7 days prior
- •to study enrolment. Patients already on these agents may be enrolled but must
- •remain on stable doses of the agent for
研究者
相似试验
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 RLSRestless Legs SyndromeMedDRA version: 8.1Level: LLTClassification code 10058920Term: Restless legs syndromeEUCTR2006-002139-26-DEGlaxoSmithKline Research & Development Limited30
招募中
不适用
Safety and tolerability evaluation study of BVAC-C in patients with HPV type 16 or 18 positive cervical cancer after failure to standard careNeoplasmsKCT0002115Cellid9
进行中（未招募）
1 期
An open label, dose escalation study with a double blind randomised placebo controlled withdrawal to examine the effects of the histamine H3 antagonist GSK189254 in patients with narcolepsy.arcolepsyMedDRA version: 8.1Level: LLTClassification code 10028713Term: NarcolepsyEUCTR2006-002088-18-NLGlaxoSmithKline Research & Development Ltd
进行中（未招募）
不适用
An open label, dose escalation study with a double blind randomised placebo controlled withdrawal to examine the effects of the histamine H3 antagonist GSK189254 in patients with narcolepsy.EUCTR2006-002088-18-DEGlaxoSmithKline Research & Development Ltd120
进行中（未招募）
不适用
An open label, dose escalation study with a double blind randomised placebo controlled withdrawal to examine the effects of the histamine H3 antagonist GSK189254 in patients with narcolepsy.EUCTR2006-002088-18-ATGlaxoSmithKline Research & Development Ltd105