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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00331721
• Other study ID #: PN06-CLD-01001
• Status: Terminated
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: May 21, 2008
• Start date: May 2006
• Est. completion date: May 2009

Study information

• Verified date: May 2008
• Source: PAION Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyBelgium: Federal Agency for Medicinal Products and Health ProductsGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Enecadin
Dose escalating
• Placebo
Placebo comparator

Locations

Country	Name	City	State
Austria	Investigational Site 1	Linz
Austria	Investigational Site 2	Linz
Belgium	Investigational Site	Antwerpen
Belgium	Investigational Site	Brugge
Belgium	Investigational Site	Leuven
Germany	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

Sponsors (1)

Lead Sponsor	Collaborator
PAION Deutschland GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety parameters, Pharmacokinetics & trends of efficacy		One month	No

External Links

•   PAION Deutschland GmbH