EUCTR2004-002437-39-BE进行中（未招募）不适用
A Phase IIb Randomized, Double-Blind, Placebo-Controlled, Group-Sequential, Multicenter, Dose Finding Study of the Safety and Efficacy of SUN N4057 (Piclozotan)Administered for 72 Hours by Continuous Intravenous Infusion in Subjects with Acute Ischemic Stroke and Measurable Penumbra on MRI.
Daiichi Asubio Pharmaceuticals Inc.0 个研究点目标入组 206 人开始时间: 2005年8月23日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 206
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
- •General Inclusion Criteria
- •1.Males or females >= 18 and <= 85 years of age at randomization. Female subjects must be either:
- •- Surgically sterile
- •- Post-menopausal for at least 1 year
- •- Non pregnant confirmed by serum pregnancy test, and using a method
- •of birth control that is acceptable to the investigator.
- •2.Neurological examination demonstrating localizing cortical signs
- •3.Receipt of study drug less than 6 hours (50% of subjects) or between 6 and 9 hours, inclusive, (50% of subjects) after the onset of symptoms (for un-witnessed stroke, last time seen in normal state or at bedtime for un-witnessed stroke during sleep)
- •4.Signed informed consent from subject or a legally acceptable representative
- •5.NIHSS score of 6 - 22, inclusive, or at least 2 on the aphasia item of the NIHSS with a location of MRI findings consistent with aphasia
- •MRI-Determined Inclusion Criteria
- •1.Acute ischemic stroke with substantial cortical involvement in the middle cerebral
- •artery (MCA) distribution, as verified by the Screening DWI abnormality and/or Screening PWI abnormality. (Note: white matter involvement, in addition to cortex, is not an exclusion.)
- •2.DWI with the longest diameter in any plane of at least 2 cm and no longer than 8 cm
- •3.PWI with the longest diameter in any plane of at least 3 cm
- •4.Screening PWI abnormality exceeding the Screening DWI abnormality (mismatch) by 50% in volume or > 1 cm in diameter
- •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
- •General Exclusion Criteria:
- •1.Two or more of the following:
- •a.Reduced level of consciousness (score ? 2 on NIHSS Q1a)
- •b.Forced eye deviation or total gaze paresis (score of 2 on NIHSS Q2)
- •c.Dense hemiplegia (no movement) of upper and lower extremities (score of 4 on NIHSS Q5 regarding motor arm and a score of 4 on NIHSS Q6 regarding motor leg)
- •2.Pre-stroke Modified Rankin score ? 2 at Screening
- •3.Rapid neurological improvement from Screening up to the start of drug infusion
- •4.Persistent systolic blood pressure (SBP) > 220 mmHg and/or diastolic blood pressure (DSP) > 120 mmHg (confirmed by at least three readings taken at least 3 minutes apart) prior to randomization. If subsequent readings are consistently below these levels, either spontaneously or following mild antihypertensive therapy, the subject may be enrolled.
- •5.Aggressive anti-hypertensive therapy required to maintain blood pressure at acceptable levels
- •6.Female subjects who are pregnant and/or nursing, confirmed by serum pregnancy test
- •7.Administration of an investigational product within the past 30 days
- •8.Currently taking any selective serotonin reuptake inhibitor (SSRI) and/or other medications listed in Section 9.9 and Attachment II of the protocol
- •9.Significant renal dysfunction as defined by a serum creatinine > 2.5 mg/dL and a creatinine clearance < 30 mL/min based on Cockroft-Gault formula
- •10.Significant hepatic disease as defined by liver function tests (LFT) ? 3 times the upper limit of normal
- •11.Seizure during the current stroke episode
- •12.Received, or is a candidate to receive, thrombolytics for the current stroke episode
- •13.Life expectancy of less than 90 days
- •14.Another significant neurologic disease or previous stroke in addition to the current stroke that would, in the opinion of the Investigator, interfere with the neurological assessment
- •15.Myocardial infarction within 3 months of study entry
- •16.Unstable angina pectoris
- •17.Congestive heart failure with symptoms either at rest or minimal exertion (New York Heart Association [NYHA] Class III or IV)
- •18.Cardiac conduction system abnormality including second or third degree atrioventricular (AV) block
- •19.Sinus bradycardia (resting heart rate< 50 beats per minute) or a history of sick sinus syndrome
- •20.Evidence of QTc prolongation (>450 milliseconds) on Screening ECG
- •21.Known history of symptomatic orthostatic hypotension
- •22.Persistent elevation of glucose > 300 mg/dL during screening
- •23.Cancer under active treatment
- •24.Received known cytochrome P450 3A4 inhibitors including azole antifungal agents (e.g., ketoconazole, itraconazole) within 24 hours prior to Hour 0 and for 3 days after Hour 72. An appropriate longer washout period is required for drugs with a longer half-life.
- •MRI-Determined Exclusion Criteria
- •1.Intracranial hemorrhage as verified by the Screening MRI (or a computerized tomography [CT] scan performed pre-screening)
- •2.Subacute stroke in a symptomatic region of the brain verified by significant T2 shine through on the Screening FLAIR MRI
- •3.Significant mass effect, edema, or midline shift including Screening DWI abnormality greater than 2/3 of the MCA territory
- •4.DWI longest diameter greater than 8 cm or less than 2 cm
- •5.No Screening PWI abnormality and therefore no PWI/DWI mismatch
- •6.Contraindication to MRI (ferrous implants, cardiac pacemakers, claustrophobia, or known sensitivity to MRI contrast agents)
- •7.Severe agitation that precludes MRI
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