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Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS) (DEDAS)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Desmoteplase
Desmoteplase
Placebo
Sponsored by
PAION Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Acute ischemic stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Desmoteplase 90µg/kg BW

    Desmoteplase 125 µg/kg BW

    Placebo

    Outcomes

    Primary Outcome Measures

    National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
    Reperfusion after 4-8 h
    Infarct lesion volume after 30 days
    Safety & pharmacokinetic outcomes

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2008
    Last Updated
    March 12, 2008
    Sponsor
    PAION Deutschland GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00638248
    Brief Title
    Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)
    Acronym
    DEDAS
    Official Title
    International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    October 2004 (Actual)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    PAION Deutschland GmbH

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Acute ischemic stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Desmoteplase 90µg/kg BW
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Desmoteplase 125 µg/kg BW
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Desmoteplase
    Intervention Description
    Desmoteplase 90µg/kg BW i.v. bolus
    Intervention Type
    Drug
    Intervention Name(s)
    Desmoteplase
    Intervention Description
    Desmoteplase 125 µg/kg BW i.v. bolus
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo i.v. bolus
    Primary Outcome Measure Information:
    Title
    National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
    Time Frame
    Day 90
    Title
    Reperfusion after 4-8 h
    Time Frame
    8 h
    Title
    Infarct lesion volume after 30 days
    Time Frame
    Day 30
    Title
    Safety & pharmacokinetic outcomes
    Time Frame
    Day 90

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antony J. Furlan, MD
    Organizational Affiliation
    Department of Neurology; the Cleveland Clinic Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16574922
    Citation
    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 onset. Stroke. 2006 May;37(5):1227-31. doi: 10.1161/01.STR.0000217403.66996.6d. Epub 2006 Mar 30.
    Results Reference
    result
    PubMed Identifier
    22738918
    Citation
    Warach S, Al-Rawi Y, Furlan AJ, Fiebach JB, Wintermark M, Lindsten A, Smyej J, Bharucha DB, Pedraza S, Rowley HA. Refinement of the magnetic resonance diffusion-perfusion mismatch concept for thrombolytic patient selection: insights from the desmoteplase in acute stroke trials. Stroke. 2012 Sep;43(9):2313-8. doi: 10.1161/STROKEAHA.111.642348. Epub 2012 Jun 26.
    Results Reference
    derived
    PubMed Identifier
    22474060
    Citation
    Fiebach JB, Al-Rawi Y, Wintermark M, Furlan AJ, Rowley HA, Lindsten A, Smyej J, Eng P, Warach S, Pedraza S. Vascular occlusion enables selecting acute ischemic stroke patients for treatment with desmoteplase. Stroke. 2012 Jun;43(6):1561-6. doi: 10.1161/STROKEAHA.111.642322. Epub 2012 Apr 3.
    Results Reference
    derived
    Links:
    URL
    http://www.paion.de
    Description
    PAION Deutschland GmbH

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    Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)

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