DP-b99
DP-BAPTA
Action
Membrane activated metal ion chelator intended to reduce pathological metal ion levels once activated.
Status
Phase I trial in Germany initiated 2000. "Randomized trial of DP-b99 or placebo administered as an intravenous infusion to a total of 24 volunteers at doses ranging from 3 to 1000 micrograms/kg. The compound was well tolerated and no cardiovascular or central nervous system side-effects were noted, even at the highest dose administered. Only mild, transient adverse effects such as injection site reaction, headache and nausea, were reported."
Phase II trial initiated 9/11/01 as a randomized, double-blind, placebo-controlled trial. The purpose of the study was to determine whether DP-b99 could be safely used in patients within a 12-hour time window following a stroke incident and to provide important pharmacokinetics and dosing information for future pivotal efficacy trials. Analysis of the data indicates that DP-b99 may be safely administered in this patient population. Rates of mortality, serious adverse events and overall adverse events were not higher in the DP-b99 group compared to placebo and no major side effects were attributed to the treatment. Efficacy evaluation demonstrates improvements in the clinical neurological scale score (NIHSS) 2, 7 and 30 days after the stroke in drug-treated patients.
Trial(s)
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Trials
Directories