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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 October 2012
Main ID:  NCT00638248
Date of registration: 12/03/2008
Primary sponsor: PAION Deutschland GmbH
Public title: Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS) DEDAS
Scientific title: International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke
Date of first enrolment: March 2003
Target sample size: 38
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00638248
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment  
Countries of recruitment
Contacts
Name:   Antony J. Furlan, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Neurology; the Cleveland Clinic Foundation
Key inclusion & exclusion criteria

Inclusion Criteria:

- scoring 4 to 20 on the National Institute of Health Stroke Scale (NIHSS)

- showing a perfusion-diffusion mismatch on MRI of 20 %

- enrolment within a 3 h to 9 h time window after symptom onset.

- 18-85 years of age

Exclusion Criteria:

- Participation in any interventional trial in the previous 30 days.

- Women in the childbearing age.

- Any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm,
arteriovenous malformation or aneurysm.

- Conditions that, according to the judgment of the investigator, might impose an
additional risk to any individual stroke patient when receiving study medication
(this applied to patients on platelet-function inhibitors as well).

- MRI exclusion criteria: Evidence of ICH, Evidence of SAH, Signs of extensive early
infarction on DWI assessed by evidence of involvement of >1/3 of the middle cerebral
artery (MCA) territory. No perfusion deficit, Internal carotid artery (ICA) occlusion
ipsilateral to stroke lesion without additional ipsilateral MCA, anterior cerebral
artery (ACA) or posterior cerebral artery (PCA) occlusion. Any intracranial pathology
that would interfere with the MRI assessment of acute ischemic stroke.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Stroke
Intervention(s)
Drug: Desmoteplase
Drug: Placebo
Primary Outcome(s)
Infarct lesion volume after 30 days [Time Frame: Day 30]
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS [Time Frame: Day 90]
Reperfusion after 4-8 h [Time Frame: 8 h]
Safety & pharmacokinetic outcomes [Time Frame: Day 90]
Secondary Outcome(s)
Secondary ID(s)
PN01-CLD-000002/01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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