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

Phase 2

Terminated

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Enecadin

• Registration Number: NCT00331721
• Lead Sponsor: PAION Deutschland GmbH

Brief Summary

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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-21
• Last Update Posted: 2008-05-22
• Primary Completion: 2009-05
• Study Completion: 2009-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Enecadin	Enecadin

Primary Outcome Measures

Name	Time	Method
Safety parameters, Pharmacokinetics & trends of efficacy	One month

Trial Locations

Locations (4)

Investigational Site 1; 🇦🇹 Linz, Austria

Investigational Site 2; 🇦🇹 Linz, Austria

Investigational Site; 🇩🇪 Wiesbaden, Germany

University of Heidelberg; 🇩🇪 Heidelberg, Germany