Study to Assess the Safety and Efficacy of THR-18 When Administered to Patients Suffering Acute Ischemic Stroke and Treated With Tissue Plasminogen Activator (tPA)

NCT01253512 | Unknown Phase 1 DMC

• 2 other identifiers: THR-2010-01THR-18 pilot stroke study
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, double-blind, placebo-controlled, multi-center, multi-national, escalating dose, pilot study comparing two doses of THR-18 to placebo when administered to patients suffering acute ischemic stroke and treated with Tissue Plasminogen Activator (tPA). The study hypothesis is that THR-18 will be safe and well tolerated in subjects suffering acute ischemic stroke and treated with Thrombolysis.

Conditions

Acute Ischemic Stroke

Keywords

Ischemic Stroke; Thrombolysis

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Safety and tolerability parameters include evaluation of: 1. No of subjects experiencing adverse events throughout the study 2. Changes for start of study in clinical safety laboratory blood tests 3. Changes in hemodynamic parameters throughout the study 4. Number of subjects experiencing intra-cranial hemorrhage throughout the study

  3 months

Secondary Outcomes (1)

• Number of subjects achieving favourable neurological outcome as assessed by National Institutes of Health Stroke Scale (NIHSS) NIHSS and Modified Rankin Scale (mRS) categorical analysis at 1 and 3 months post drug administration.

  30 and 90 days from stroke onset

Study Arms (3)

THR-18 0.25mg/kg

EXPERIMENTAL

Treatment with combination with Tissue Plasminogen Activator (tPA) treatment

Drug: THR-18

Placebo treatment

PLACEBO COMPARATOR

Treatment in combination with Tissue Plasminogen Activator (tPA) treatment

Drug: Placebo

THR-18 0.5mg/kg

EXPERIMENTAL

Treatment in combination with Tissue Plasminogen Activator (tPA) treatment

Drug: THR-18

Interventions

THR-18 DRUG

A single 0.25 or 0.5 mg/kg of THR-18 in combination with tPA treatment.

THR-18 0.25mg/kg; THR-18 0.5mg/kg

Placebo DRUG

Intravenous

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Diagnosis of acute ischemic stroke onset less than 3 hours prior to the planned start of intravenous Tissue Plasminogen Activator (tPA).
• Have suffered an acute hemispheric ischemic stroke, defined as acute, focal, neurological deficit(s) and secondary to a presumed vascular event.
• Age 18-85 years both inclusive.
• Able to sign informed consent.

You may not qualify if:

• Participation in another study with an investigational drug or device within 30 days of study entry, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 30) assessment in this trial.
• Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence.
• Symptoms suggestive of subarachnoid hemorrhage, even if computed tomography perfusion scan(CT)or magnetic resonance imaging (MRI) scan is negative for hemorrhage.
• Evidence of acute myocardial infarction.
• Acute Pericarditis
• Patients who would refuse blood transfusions if medically indicated.
• Neurological deficit that has led to stupor or coma (National Institutes of Health Stroke Scale (NIHSS) level of consciousness score greater than or equal to 2).
• High clinical suspicion of septic embolus.
• Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
• Baseline NIHSS greater than 18 for left hemisphere stroke or greater than 15 for others.
• Evidence of acute or chronic Intra cranial Hemorrhage (ICH) by head CT or MRI.
• CT or MRI evidence of non-vascular cause for the neurological symptoms.
• Signs of mass effect causing shift of midline structures on CT or MRI.
• Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg not controlled by antihypertensive therapy or requiring nitroprusside for control.
• Blood glucose greater than 200 mg/dl.

Sponsors & Collaborators

• Thrombotech Ltd.: lead

Study Sites (1)

Hadassah Medical Center,

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ronen R. Leker, MD, FAHA

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnon Aharon

CONTACT

972545500702; arnon@rnd-is.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 3, 2010
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 3, 2010

Record last verified: 2010-12

Locations

IL (1)