A Phase 1-2, Randomized, Placebo-Controlled, Single-Blind, Dose Escalation Study to Evaluate the Safety, Tolerability, and Activity of Ascending Single Doses of MRX-801 with Continuous Ultrasound Administration in Subjects with Acute Ischemic Stroke Receiving Treatment with Intravenous Tissue Plasminogen Activator

• Conditions: Acute Ischemic Stroke; MedDRA version: 8.1Level: LLTClassification code 10055221Term: Ischemic stroke

• Registration Number: EUCTR2006-005491-40-DE
• Lead Sponsor: ImaRx Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
1. Males or females 18 years of age or older.

2. Patients with a diagnosis of intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA), or distal basilar artery as demonstrated by US.

3. Patients with neurological deficit measurable by NIHSS score, and that in the opinion of the treating physician requires treatment with full dose IV tPA.

4. Patients with persisting arterial occlusion and without frank resolution of neurological symptoms at the time of diagnostic ultrasound imaging, who, in accordance with local
and federal guidelines for use, are eligible for intravenous tPA or have been receiving
intravenous tPA for up to 45 minutes

5. Provision of informed consent as demonstrated by the patient’s signature or by the signature of the patient’s authorized legal representative on the Informed Consent Form in accordance with all local and federal regulations.

6. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and federal regulations.

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

Patients presenting with any of the following will not be included in the trial:

1. Evidence of hemorrhage on non-contrast head CT or MRI scan;

2. Patients with primary intra-arterial thrombolysis.

3. Patients with known right-to-left cardiac shunts as determined from medical history or patient chart.

4. Patients with any known hypersensitivity to the test article or any other diagnostic agents or therapeutics to be used.

5. Patients without temporal insonation windows.

6. Female and pregnant or breast feeding.

7. Patients receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment.

8. Patients with any standard contraindication for intravenous tPA therapy.

9. Patients with moderate to severe COPD (baseline O2 saturation less than 80% on room air);

10. Significant concurrent medical/neurological conditions or deviation from normal laboratory test values at baseline that, in the opinion of the investigator, pose significant risk to the patient and warrant exclusion from the study.

Study & Design

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