Treatment of acute stroke.
Conditions
Interventions
Product Name: Piclozotan
Product Code: SUN N4057
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of the placebo: Intravenous
Sponsors
Daiichi Asubio Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria 1. Males or females >= 18 and 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
Exclusion criteria
Exclusion criteria: 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 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. 25. Experienced vomiting since beginning of stroke symptoms. 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 an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the efficacy of a 72 hour infusion of SUN N4057 in subjects with clinical findings of an acute ischemic stroke and an MRI demonstrating a measurable penumbra (perfusion-weighted imaging [PWI] minus diffusion-weighted imaging [DWI] volume). Efficacy will be determined by comparing the proportion of subjects with no growth in stroke lesion volume between Screening and Day 28, with stroke lesion volume assessed by DWI at Screening and by FLAIR (fluid-attenuated inversion recovery) at Day 28, in the SUN N4057 group versus the placebo group. ;Secondary Objective: The study drug was administered for a period of 72 hours, and patients were followed up for 90 days. 1. To compare the SUN N4057 group versus the placebo group for: - The absolute change in stroke lesion volume and percent change in stroke lesion volume between Screening to Day 28; - The clinical outcomes at Day 28 and 90 using the individual clinical scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale [NIHSS]); - The global test statistic (GTS) at Days 28 and 90 using the results on the Modified Rankin Scale, Barthel Index, and NIHSS; - All-cause-mortality at Day 28 and 90; and 2. To assess the safety and tolerability of SUN N4057 in subjects with acute stroke. ;Primary end point(s): Although the treatment period will last 72 hours, patients will be followed up for 90 Days. MRIs will be performed at Screening, Hour 12 of administration, and Day 28 of the study. Efficacy will be assessed by comparing the proportion of subjects who have no growth in stroke lesion volume as assessed by DWI on MRI at Screening to stroke lesion volume assessed by FLAIR on Day 28 (primary end-point). | — |
Countries
Germany, Spain
Outcome results
None listed