Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)

Stroke Clinical Trial

— DEDAS  

Official title:

International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638248
• Other study ID #: PN01-CLD-000002/01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 12, 2008
• Last updated: March 12, 2008
• Start date: March 2003
• Est. completion date: October 2004

Study information

• Verified date: March 2008
• Source: PAION Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.

Description:

Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability in adults. The outcome can be improved by early treatment with thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of acute ischemic stroke. However, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.

Desmoteplase (DSPA) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Desmoteplase
Desmoteplase 90µg/kg BW i.v. bolus
• Desmoteplase
Desmoteplase 125 µg/kg BW i.v. bolus
• Placebo
Placebo i.v. bolus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
PAION Deutschland GmbH

References & Publications (1)

Furlan AJ, Eyding D, Albers GW, Al-Rawi Y, Lees KR, Rowley HA, Sachara C, Soehngen M, Warach S, Hacke W; DEDAS Investigators. Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS): evidence of safety and efficacy 3 to 9 hours after stroke onse — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS		Day 90	No
Primary	Reperfusion after 4-8 h		8 h	No
Primary	Infarct lesion volume after 30 days		Day 30	No
Primary	Safety & pharmacokinetic outcomes		Day 90	No

External Links

•   PAION Deutschland GmbH
•   Study Publication