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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

Tracking Information
First Submitted Date  ICMJE May 30, 2006
First Posted Date  ICMJE May 31, 2006
Last Update Posted Date May 22, 2008
Study Start Date  ICMJE May 2006
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 29, 2008)
Safety parameters, Pharmacokinetics & trends of efficacy [ Time Frame: One month ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00331721 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST
Official Title  ICMJE A Multicentre, Double-Blind, Randomised, Placebo-Controlled, Dose-Escalating Parallel-Group Study to Investigate the Tolerability of Enecadin (INN) in Acute Ischemic Stroke
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE
  • Drug: Enecadin
    Dose escalating
  • Drug: Placebo
    Placebo comparator
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Enecadin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 21, 2008)
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE May 2009
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00331721
Other Study ID Numbers  ICMJE PN06-CLD-01001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development, PAION Deutschland GmbH
Study Sponsor  ICMJE PAION Deutschland GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter A Ringleb, Dr. Heidelberg University
PRS Account PAION Deutschland GmbH
Verification Date May 2008

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