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

This study has been terminated.
(Scientific data called into question the viability of the substance class)
Sponsor:
Information provided by:
PAION Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT00331721
First received: May 30, 2006
Last updated: May 21, 2008
Last verified: May 2008
History of Changes

May 30, 2006
May 21, 2008
May 2006
May 2009   (final data collection date for primary outcome measure)
Safety parameters, Pharmacokinetics & trends of efficacy [ Time Frame: One month ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00331721 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Stroke
  • Drug: Enecadin
    Dose escalating
  • Drug: Placebo
    Placebo comparator
  • Active Comparator: 1
    Enecadin
    Intervention: Drug: Enecadin
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Germany
 
NCT00331721
PN06-CLD-01001
Yes
Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development, PAION Deutschland GmbH
PAION Deutschland GmbH
Not Provided
Principal Investigator: Peter A Ringleb, Dr. University of Heidelberg
PAION Deutschland GmbH
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP