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Sponsored by: |
PAION Deutschland GmbH |
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Information provided by: | PAION Deutschland GmbH |
ClinicalTrials.gov Identifier: | NCT00638781 |
The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.
Condition | Intervention | Phase |
---|---|---|
Stroke |
Drug: Desmoteplase Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke |
Enrollment: | 104 |
Study Start Date: | March 2001 |
Study Completion Date: | October 2003 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Desmoteplase 62.5 µg/kg BW i.v. bolus
|
Drug: Desmoteplase
Desmoteplase 62.5 µg/kg BW
|
2: Active Comparator
Desmoteplase 90 µg/kg BW i.v. bolus
|
Drug: Desmoteplase
Desmoteplase 90 µg/kg BW
|
3: Active Comparator
Desmoteplase 125 µg/kg BW i.v. bolus
|
Drug: Desmoteplase
Desmoteplase 125 µg/kg BW
|
4: Placebo Comparator
Placebo i.v. bolus
|
Drug: Placebo
Placebo
|
Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability. 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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | PAION Deutschland GmbH ( Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development ) |
Study ID Numbers: | PN01-CLD-000001/01 |
Study First Received: | March 12, 2008 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00638781 History of Changes |
Health Authority: | Australia: National Health and Medical Research Council; Austria: Agency for Health and Food Safety; Belgium: Ministry of Social Affairs, Public Health and the Environment; Finland: Ministry of Social Affairs and Health; France: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Norway: Norwegian Medicines Agency; Singapore: Health Sciences Authority; Spain: Spanish Agency of Medicines; Switzerland: Federal Office of Public Health; United Kingdom: Department of Health |
Acute ischemic stroke |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents Ischemia Brain Diseases |
Cerebrovascular Disorders Fibrin Modulating Agents Brain Ischemia Brain Infarction Infarction Salivary plasminogen activator alpha 1, Desmodus rotundus Plasminogen |
Molecular Mechanisms of Pharmacological Action Cerebral Infarction Hematologic Agents Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Fibrinolytic Agents Cardiovascular Agents |
Brain Diseases Cerebrovascular Disorders Pharmacologic Actions Fibrin Modulating Agents Therapeutic Uses Brain Ischemia Cardiovascular Diseases Brain Infarction Salivary plasminogen activator alpha 1, Desmodus rotundus |