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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalating Parallel-Group Study to Investigate the Tolerability of Enecadin (INN) in Acute Ischemic Stroke

Conditions
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Stroke

Intervention / Treatment
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* Drug: Enecadin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute ischemic stroke (scoring 3-20 on the National Institutes of Health Stroke Scale [NIHSS]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms. For female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago). Exclusion Criteria: Participation in any investigational study in the previous 30 days. Patients unable to understand trial related information. History or evidence of severe heart diseases further specified in the protocol. History or evidence of additional diseases or results of baseline visit as specified in the protocol. Use of concomitant and prior medications as defined in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Enecadin | Drug: Enecadin<br>* Dose escalating<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters, Pharmacokinetics & trends of efficacy |  | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Ischemic Stroke