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

Sponsored by:	PAION Deutschland GmbH
Information provided by:	PAION Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00331721

Purpose

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	Intervention	Phase
Stroke	Drug: Enecadin Drug: Placebo	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study
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

Further study details as provided by PAION Deutschland GmbH:

Primary Outcome Measures:

Safety parameters, Pharmacokinetics & trends of efficacy [ Time Frame: One month ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	May 2006
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Enecadin	Drug: Enecadin Dose escalating
2: Placebo Comparator Placebo	Drug: Placebo Placebo comparator

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00331721

Locations

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

Sponsors and Collaborators

PAION Deutschland GmbH

Investigators

Principal Investigator:

Peter A Ringleb, Dr.

University of Heidelberg

More Information

PAION Deutschland GmbH This link exits the ClinicalTrials.gov site

Responsible Party:	PAION Deutschland GmbH ( Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development )
Study ID Numbers:	PN06-CLD-01001
Study First Received:	May 30, 2006
Last Updated:	May 21, 2008
ClinicalTrials.gov Identifier:	NCT00331721
Health Authority:	Austria: Agency for Health and Food Safety; Belgium: Federal Agency for Medicinal Products and Health Products; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by PAION Deutschland GmbH:

Acute Ischemic Stroke

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Brain Infarction
Ischemia
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009