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

Primary Purpose

Stroke

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Enecadin
Placebo
Sponsored by
PAION Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute Ischemic Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site 1
  • Investigational Site 2
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  • University of Heidelberg
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Enecadin

Placebo

Outcomes

Primary Outcome Measures

Safety parameters, Pharmacokinetics & trends of efficacy

Secondary Outcome Measures

Full Information

First Posted
May 30, 2006
Last Updated
May 21, 2008
Sponsor
PAION Deutschland GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00331721
Brief Title
Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST
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 Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Scientific data called into question the viability of the substance class
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
PAION Deutschland GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Enecadin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Enecadin
Intervention Description
Dose escalating
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Safety parameters, Pharmacokinetics & trends of efficacy
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Ringleb, Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site 1
City
Linz
Country
Austria
Facility Name
Investigational Site 2
City
Linz
Country
Austria
Facility Name
Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
Investigational Site
City
Brugge
Country
Belgium
Facility Name
Investigational Site
City
Leuven
Country
Belgium
Facility Name
Investigational Site
City
Aachen
Country
Germany
Facility Name
Investigational Site
City
Bad Neustadt
Country
Germany
Facility Name
Investigational Site
City
Bergisch Gladbach
Country
Germany
Facility Name
Investigational Site
City
Berlin
Country
Germany
Facility Name
Investigational Site
City
Bochum
Country
Germany
Facility Name
Investigational Site
City
Dortmund
Country
Germany
Facility Name
Investigational Site
City
Dresden
Country
Germany
Facility Name
Investigational Site
City
Erlangen
Country
Germany
Facility Name
Investigational Site
City
Frankfurt
Country
Germany
Facility Name
Investigational Site
City
Freiburg
Country
Germany
Facility Name
Investigational Site
City
Hamburg
Country
Germany
Facility Name
Investigational Site
City
Hannover
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Investigational Site
City
Ingolstadt
Country
Germany
Facility Name
Investigational Site
City
Leipzig
Country
Germany
Facility Name
Investigational Site
City
Magdeburg
Country
Germany
Facility Name
Investigational Site
City
Minden
Country
Germany
Facility Name
Investigational Site
City
Munich
Country
Germany
Facility Name
Investigational Site
City
Nurenberg
Country
Germany
Facility Name
Investigational Site
City
Remscheid
Country
Germany
Facility Name
Investigational Site
City
Wiesbaden
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.paion.de
Description
PAION Deutschland GmbH

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

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