Double blind, placebo controlled, escalating single-dose, pilot study to assess the safety of THR-18 when administered to patients suffering acute ischemic stroke and treated with tPA

• Conditions: Acute isquemic stroke; MedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005317-37-ES
• Lead Sponsor: Thrombotech Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-11
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1)Male or female.
2)Diagnosis of acute ischemic stroke onset less than 3 hours prior to the planned start of intravenous tPA (alteplase).
3)Have suffered an acute hemispheric ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following:
?At least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11):
oLanguage dysfunction (aphasic disorder, excluding dysarthria)
oVisual field defect (excluding monocular blindness)
oExtinction and Inattention (formerly Neglect)
?An indication on routine diffusion-weighted magnetic resonance imaging (DW-MRI) or computed tomography perfusion scan at screening /baseline that the acute stroke involves the cerebral cortex
4)NIHSS larger > 5 and < 18 for left and right hemisphere strokes.
5)Age 18-85 years both inclusive.
6)Signed informed consent from patient or legally authorized representative or an independent witness or an independent physician, if applicable according to the Details about the consent procedure described in country-specific supplements to this protocol.
7)Subjects are indicated for the application of intravenous tPA (alteplase).
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

2)Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence.
3)Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
7)Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2).
8)High clinical suspicion of septic embolus.
9)Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
10)Baseline NIHSS greater than 18 for left and right hemisphere stroke.
11)Evidence of acute or chronic ICH by head CT or MRI.
14)Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
15)Blood glucose greater than 200 mg/dl.
18)Have suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke.
32)Subjects with disabling congestive heart failure (CHF) or unstable angina.
34)Subjects that suffered a myocardial infarction in the last 90 days.
47)Have a positive urine pregnancy test at screening/baseline or be a lactating female.
48)Any condition that in the investigator?s judgement precludes participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified