Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST

Terminated

Phase 2 Results N/A

Trial Description

The main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. Furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. Efficacy trends will be evaluated up to day 30 post stroke.

Detailed Description

In the acute stage of ischemic stroke, an ischemic core characterized by a marked decrease in blood flow is present, leading to irreversible neuronal damage at an early stage. Around the boundary of the ischemic core, there is a region called ischemic penumbra in which functional recovery is possible after recirculation of blood flow within several hours after the onset, even though the blood flow is markedly decreased. Prevention of nerve cell death in the ischemic penumbra by neuroprotective therapy should greatly improve outcome and prognosis of acute ischemic stroke.

Trial Stopped: Scientific data called into question the viability of the substance class

Conditions

Interventions

  • Enecadin Drug
    Intervention Desc: Dose escalating
    ARM 1: Kind: Experimental
    Label: 1
    Description: Enecadin
  • Placebo Drug
    Intervention Desc: Placebo comparator
    ARM 1: Kind: Experimental
    Label: 2
    Description: Placebo

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety parameters, pharmacokinetics and trends of efficacy.
Primary Safety parameters, Pharmacokinetics & trends of efficacy One month No

Sponsors