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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00331721
Recruitment Status : Terminated (Scientific data called into question the viability of the substance class)
First Posted : May 31, 2006
Last Update Posted : May 22, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Stroke Drug: Enecadin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalating Parallel-Group Study to Investigate the Tolerability of Enecadin (INN) in Acute Ischemic Stroke
Study Start Date : May 2006
Estimated Primary Completion Date : May 2009
Estimated Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: 1
Drug: Enecadin
Dose escalating

Placebo Comparator: 2
Drug: Placebo
Placebo comparator

Primary Outcome Measures :
  1. Safety parameters, Pharmacokinetics & trends of efficacy [ Time Frame: One month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00331721

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Investigational Site 1
Linz, Austria
Investigational Site 2
Linz, Austria
Investigational Site
Antwerpen, Belgium
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Brugge, Belgium
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Leuven, Belgium
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Aachen, Germany
Investigational Site
Bad Neustadt, Germany
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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
University of Heidelberg
Heidelberg, Germany
Investigational Site
Ingolstadt, Germany
Investigational Site
Leipzig, Germany
Investigational Site
Magdeburg, Germany
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Minden, Germany
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Munich, Germany
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Nurenberg, Germany
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Remscheid, Germany
Investigational Site
Wiesbaden, Germany
Sponsors and Collaborators
PAION Deutschland GmbH
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Principal Investigator: Peter A Ringleb, Dr. Heidelberg University

Additional Information:
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Responsible Party: Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development, PAION Deutschland GmbH Identifier: NCT00331721     History of Changes
Other Study ID Numbers: PN06-CLD-01001
First Posted: May 31, 2006    Key Record Dates
Last Update Posted: May 22, 2008
Last Verified: May 2008

Keywords provided by PAION Deutschland GmbH:
Acute Ischemic Stroke

Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases