Clinical trial NCT00331721: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stroke
Keywords: Acute Ischemic Stroke
Lead sponsor: PAION Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Safety parameters, Pharmacokinetics & trends of efficacy
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Investigational Site 1
city: Linz
country: Austria
facility: Investigational Site 2
city: Antwerpen
country: Belgium
facility: Investigational Site
city: Brugge
country: Belgium
facility: Investigational Site
city: Leuven
country: Belgium
facility: Investigational Site
city: Aachen
country: Germany
facility: Investigational Site
city: Bad Neustadt
country: Germany
facility: Investigational Site
city: Bergisch Gladbach
country: Germany
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Bochum
country: Germany
facility: Investigational Site
city: Dortmund
country: Germany
facility: Investigational Site
city: Dresden
country: Germany
facility: Investigational Site
city: Erlangen
country: Germany
facility: Investigational Site
city: Frankfurt
country: Germany
facility: Investigational Site
city: Freiburg
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Hannover
country: Germany
facility: Investigational Site
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Ingolstadt
country: Germany
facility: Investigational Site
city: Leipzig
country: Germany
facility: Investigational Site
city: Magdeburg
country: Germany
facility: Investigational Site
city: Minden
country: Germany
facility: Investigational Site
city: Munich
country: Germany
facility: Investigational Site
city: Nurenberg
country: Germany
facility: Investigational Site
city: Remscheid
country: Germany
facility: Investigational Site
city: Wiesbaden
country: Germany
facility: Investigational Site
Study officials:
affiliation: Heidelberg University
name: Peter A Ringleb, Dr.
role: PRINCIPAL_INVESTIGATOR
References: