Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Drug: Desmoteplase Drug: Placebo |
Phase 1 Phase 2 |
| 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 |
| Official Title: | International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke |
- National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
- Reperfusion after 4-8 h [ Time Frame: 8 h ] [ Designated as safety issue: No ]
- Infarct lesion volume after 30 days [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
- Safety & pharmacokinetic outcomes [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | March 2003 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Desmoteplase 90µg/kg BW
|
Drug: Desmoteplase
Desmoteplase 90µg/kg BW i.v. bolus
|
|
Active Comparator: 2
Desmoteplase 125 µg/kg BW
|
Drug: Desmoteplase
Desmoteplase 125 µg/kg BW i.v. bolus
|
|
Placebo Comparator: 3
Placebo
|
Drug: Placebo
Placebo i.v. bolus
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development, PAION Deutschland GmbH |
| ClinicalTrials.gov Identifier: | NCT00638248 History of Changes |
| Other Study ID Numbers: | PN01-CLD-000002/01 |
| Study First Received: | March 12, 2008 |
| Last Updated: | March 12, 2008 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by PAION Deutschland GmbH:
|
Acute ischemic stroke |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction |
Brain Ischemia Salivary plasminogen activator alpha 1, Desmodus rotundus Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 19, 2013