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

NCT ID: NCT00331721

Last Updated: 2008-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-05-31

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.

Conditions

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Stroke

Keywords

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Enecadin

Group Type ACTIVE_COMPARATOR

Enecadin

Intervention Type DRUG

Dose escalating

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator

Interventions

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Enecadin

Dose escalating

Intervention Type DRUG

Placebo

Placebo comparator

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PAION Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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PAION Deutschland GmbH

Principal Investigators

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Peter A Ringleb, Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Investigational Site 1

Linz, , Austria

Site Status

Investigational Site 2

Linz, , Austria

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Antwerp, , Belgium

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Bruges, , Belgium

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Leuven, , Belgium

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Aachen, , Germany

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Bad Neustadt an der Saale, , Germany

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Bergisch Gladbach, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Erlangen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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University of Heidelberg

Heidelberg, , Germany

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Ingolstadt, , Germany

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Leipzig, , Germany

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Magdeburg, , Germany

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Minden, , Germany

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Munich, , Germany

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Nuremberg, , Germany

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Remscheid, , Germany

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Investigational Site

Wiesbaden, , Germany

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Countries

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Austria Belgium Germany

Other Identifiers

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PN06-CLD-01001

Identifier Type: -

Identifier Source: org_study_id