Adrenomedullin for ischemic stroke study

Phase 2

• Conditions: Acute non-embolic ischemic stroke; Lacunar stroke, Non-embolic, Acute, Ischemic stroke; D002544

• Registration Number: JPRN-jRCT2051190092
• Lead Sponsor: IHARA MASAFUMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-08
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1) Patients who have given written informed consent from the patient or the sponsor to participate in the clinical trial
2) Patients of the following age
(1) Up to 6 patients in both cohorts: age between 20 and 75 at the time of obtaining consent
(2) In both cohorts, after age restriction has been lifted: Patients aged 20 to 90 at the time of consent acquisition
3) Patients who can start study drug administration within 24 hours after onset of ischemic stroke
(If the time of onset is unknown, the time last seen normal is the time of onset.)
4) Patients with a new ischemic area confirmed by MRI-DWI
5) Patients with NIHSS scores of 1 or above

Exclusion Criteria

1) Patients with ischemic stroke of embolic etiology
2) Patients who are likely to develop hemorrhagic transformation (patients with extensive ischemic stroke)
3) Patients who have premorbid mRS scores of 3 or more
4) Patients with active infections
5) Patients who have received or are scheduled to receive drugs or therapy (endovascular treatment, surgical treatment, etc.) not allowed to be used for the underlying disease
6) Patients with severe consciousness impairment (Japan Coma Scale 100 or more)
7) Patients with severe renal impairment (estimated GFR less than 30 mL / min / 1.73m2)
8) Patients with severe liver damage (transaminase AST (GOT) or ALT (GPT) 100 IU / L or more)
9) Patients diagnosed as having active intracranial bleeding disease (intracranial hemorrhage, subarachnoid hemorrhage, etc.) or ruptured cerebral aneurysm by head MRI taken after onset
10) Patients with severe stenosis and obstruction of the basilar artery, internal carotid artery, and middle cerebral artery horizontal part considered to be the cause of cerebral infarction targeted in this study
11) Patients with significant ECG abnormalities (atrioventricular block of 2-3 degrees, extension of QRS interval of 120 ms or more, extension of QTcB of 450 msec or more), or clinically significant heart disease (heart failure, myocardial infarction) , Angina pectoris)
12) Patients with systolic blood pressure less than 120 mmHg
13) Patients whose pulse rate is less than 45 beats / minute or 120 beats / minute or more
14) Patients with substance abuse or alcoholism
15) Patients who cannot perform MRI
16) Patients with malignant tumors or patients who have been treated for malignant tumors
17) Patients who do not give consent to contraception from the date of obtaining consent until the end of the safety evaluation period
18) Pregnant, lactating, and possibly pregnant
19) Patient who participated in another trial within 24 weeks before obtaining consent
20) Patients who have participated in clinical trials or clinical studies using adrenomedullin
21) Patients weighing 100 kg or more (rounded to one decimal place)
22) Other patients judged by the Investigator or Investigator to be ineligible for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(1) Safety: SAE<br>(2) Efficacy: NIHSS

Secondary Outcome Measures

Name	Time	Method
(1) Safety: AE<br>(2) Efficacy: mRS