A Phase 1/2 interventional study of Desmoteplase and Desmoteplase in Stroke, sponsored by PAION Deutschland GmbH. Completed. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2008-03-19.
Sponsored by PAION Deutschland GmbH · Phase 1/2, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 38 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →PAION Deutschland GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Desmoteplase 90µg/kg BW
Drug: Desmoteplase
Desmoteplase 125 µg/kg BW
Drug: Desmoteplase
Placebo
Drug: Placebo
Desmoteplase 90µg/kg BW i.v. bolus
Desmoteplase 125 µg/kg BW i.v. bolus
Placebo i.v. bolus
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
Time frame: Day 90
Reperfusion after 4-8 h
Time frame: 8 h
Infarct lesion volume after 30 days
Time frame: Day 30
Safety & pharmacokinetic outcomes
Time frame: Day 90
No study locations are listed for this record.
This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.
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PAION Deutschland GmbH