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

March 12, 2008 updated by: PAION Deutschland GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Placebo
Drug: Placebo
Placebo i.v. bolus
ACTIVE_COMPARATOR: 1
Desmoteplase 90µg/kg BW
Drug: Desmoteplase
Desmoteplase 90µg/kg BW i.v. bolus
Drug: Desmoteplase
Desmoteplase 125 µg/kg BW i.v. bolus
ACTIVE_COMPARATOR: 2
Desmoteplase 125 µg/kg BW
Drug: Desmoteplase
Desmoteplase 90µg/kg BW i.v. bolus
Drug: Desmoteplase
Desmoteplase 125 µg/kg BW i.v. bolus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reperfusion after 4-8 h
Time Frame: 8 h
8 h
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
Time Frame: Day 90
Day 90
Infarct lesion volume after 30 days
Time Frame: Day 30
Day 30
Safety & pharmacokinetic outcomes
Time Frame: Day 90
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PAION Deutschland GmbH

Investigators

  • Principal Investigator: Antony J. Furlan, MD, Department of Neurology; the Cleveland Clinic Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (ACTUAL)

October 1, 2004

Study Completion (ACTUAL)

October 1, 2004

Study Registration Dates

First Submitted

March 12, 2008

First Submitted That Met QC Criteria

March 12, 2008

First Posted (ESTIMATE)

March 19, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2008

Last Update Submitted That Met QC Criteria

March 12, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PN01-CLD-000002/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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