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)

Not yet recruiting

Phase 1/2 Results N/A

Trial Description

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.

Detailed Description

This will be a randomized, double-blind, placebo-controlled, multi-center, multi-national, escalating dose, pilot study comparing two doses of THR-18 (0.25 and 0.5 mg/kg) to placebo when administered to patients suffering acute ischemic stroke and treated with Tissue Plasminogen Activator (tPA).
A total of 22 subjects suffering from acute ischemic stroke that are eligible for tPA treatment will be recruited into the study. Eligible for recruitment are patients with an entry National Institutes of Health Stroke Scale (NIHSS) score of 5-18 and a clinical syndrome that includes at least 1 of the following: language dysfunction, visual field defect or neglect (specifically, at least 1 point on NIHSS items 3 or 9 or 11). Alternatively, patients without at least 1 point on NIHSS items 3, 9 or 11 may be enrolled if routine diffusion-weighted magnetic resonance imaging (MRI) or computed tomography perfusion scan (CT) indicates that the acute stroke involves the cerebral cortex, and as long as the overall acute neurological deficit is within the range of 5-18 NIHSS points.
Stroke onset will be defined as the time the patient was last known to be without a new clinical deficit. Patients whose symptoms started more than 3 hours before presentation are not eligible for the study. If the stroke started during sleep, stroke onset will be recorded as the time the patient was last known to be normal.
Patients will be recruited after obtaining informed consent. Female subjects of childbearing potential (less than 2 years' postmenopausal or not surgically sterilized) will have a urine pregnancy test at baseline and will be required to use adequate and effective birth control measures for the duration of the trial. Effective birth control measures include hormonal contraception, a barrier method such as a diaphragm, intrauterine device (IUD) and/or condom with spermicide (IUD, diaphragm, condoms alone or the rhythm method are not considered reliable methods).
Patients will be randomized to receive either 0.25 or 0.5 mg/kg of THR-18 or placebo in an escalating manner. tPA should be administered as 0.9 mg/kg (10% of the total dose as an Intra Venous(IV) bolus and the reminder infused IV over 60 minutes). THR-18 bolus should be given immediately prior to the tPA bolus, and the 60 min infusion of both THR-18 and tPA will be done in parallel.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Intravenous
    ARM 1: Kind: Experimental
    Label: Placebo treatment
    Description: Treatment in combination with Tissue Plasminogen Activator (tPA) treatment
  • THR-18 Drug
    Intervention Desc: A single 0.25 or 0.5 mg/kg of THR-18 in combination with tPA treatment.
    ARM 1: Kind: Experimental
    Label: THR-18 0.25mg/kg
    Description: Treatment with combination with Tissue Plasminogen Activator (tPA) treatment
    ARM 2: Kind: Experimental
    Label: THR-18 0.5mg/kg
    Description: Treatment in combination with Tissue Plasminogen Activator (tPA) treatment

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety and tolerability 3 months Yes
Secondary 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 No

Sponsors