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

May 21, 2008 updated by: PAION Deutschland GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Investigational site 1
      • Linz, Austria
        • Investigational site 2
  • Belgium
      • Antwerpen, Belgium
        • Investigational Site
      • Brugge, Belgium
        • Investigational Site
      • Leuven, Belgium
        • Investigational Site
  • Germany
      • Aachen, Germany
        • Investigational Site
      • Bad Neustadt, Germany
        • Investigational Site
      • Bergisch Gladbach, Germany
        • Investigational Site
      • Berlin, Germany
        • Investigational Site
      • Bochum, Germany
        • Investigational Site
      • Dortmund, Germany
        • Investigational Site
      • Dresden, Germany
        • Investigational Site
      • Erlangen, Germany
        • Investigational Site
      • Frankfurt, Germany
        • Investigational Site
      • Freiburg, Germany
        • Investigational Site
      • Hamburg, Germany
        • Investigational Site
      • Hannover, Germany
        • Investigational Site
      • Heidelberg, Germany
        • University of Heidelberg
      • Ingolstadt, Germany
        • Investigational Site
      • Leipzig, Germany
        • Investigational Site
      • Magdeburg, Germany
        • Investigational Site
      • Minden, Germany
        • Investigational Site
      • Munich, Germany
        • Investigational Site
      • Nurenberg, Germany
        • Investigational Site
      • Remscheid, Germany
        • Investigational Site
      • Wiesbaden, Germany
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo comparator
Active Comparator: 1
Enecadin
Drug: Enecadin
Dose escalating

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety parameters, Pharmacokinetics & trends of efficacy
Time Frame: One month
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PAION Deutschland GmbH

Investigators

  • Principal Investigator: Peter A Ringleb, Dr., Heidelberg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

May 30, 2006

First Submitted That Met QC Criteria

May 30, 2006

First Posted (Estimate)

May 31, 2006

Study Record Updates

Last Update Posted (Estimate)

May 22, 2008

Last Update Submitted That Met QC Criteria

May 21, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN06-CLD-01001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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