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

Paion

Status and phase

Terminated

Phase 2

Conditions

Stroke

Treatments

Drug: Enecadin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00331721

PN06-CLD-01001

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.