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TerminatedNCT00331721Updated May 22, 2008

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

A Phase 2 interventional study of Enecadin and Placebo in Stroke, sponsored by PAION Deutschland GmbH. Terminated at 26 sites in 3 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-05-22.

Sponsored by PAION Deutschland GmbH · Phase 2, Interventional, and Treatment

Why this study was terminated
Scientific data called into question the viability of the substance class
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

Keywords

  • Acute Ischemic Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

PAION Deutschland GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    1

    Enecadin

    Drug: Enecadin

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugEnecadin

    Dose escalating

  • DrugPlacebo

    Placebo comparator

06

What researchers measure

Primary outcomes

  1. Safety parameters, Pharmacokinetics & trends of efficacy

    Time frame: One month

07

Study locations

26 sites
  • Investigational Site 1
    Linz, Austria
  • Investigational Site 2
    Linz, Austria
  • Investigational Site
    Antwerpen, Belgium
  • Investigational Site
    Brugge, Belgium
  • Investigational Site
    Leuven, Belgium
  • Investigational Site
    Aachen, Germany
  • Investigational Site
    Bad Neustadt, Germany
  • Investigational Site
    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
  • Investigational Site
    Minden, Germany
  • Investigational Site
    Munich, Germany
  • Investigational Site
    Nurenberg, Germany
  • Investigational Site
    Remscheid, Germany
  • Investigational Site
    Wiesbaden, Germany
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00331721
Lead sponsor
PAION Deutschland GmbH
First posted
May 31, 2006
Start date
May 2006
Primary completion
May 2009 (estimated)
Completion
May 2009 (estimated)
Last update
May 22, 2008

Study contacts

Peter A Ringleb, Dr.
principal investigator · Heidelberg University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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