Status:
TERMINATED
Tolerability of Enecadin (INN) in Acute Ischemic Stroke Trial - TEST
Lead Sponsor:
PAION Deutschland GmbH
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 w...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00331721
Start Date
May 1 2006
End Date
May 1 2009
Last Update
May 22 2008
Active Locations (26)
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1
Investigational Site 1
Linz, Austria
2
Investigational Site 2
Linz, Austria
3
Investigational Site
Antwerp, Belgium
4
Investigational Site
Bruges, Belgium