Citicoline
CerAxon® CDP-choline
Action
Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)
Status
Available in Europe. Initial multicenter trial (trial 001) completed 1996 showed benefit of 500 mg and 2000 mg doses (but not 1000 mg) compared to placebo. Second study (007) of citicoline 500 mg vs. placebo completed 1997, showed no overall difference in outcome or mortality, but subgroup analysis suggested benefit for citicoline in patients presenting with mod-severe strokes. Phase II trial (010) found no difference in infarct size or neurologic function with 500 mg citicoline compared to placebo. Phase III trial comparing 2000 mg to placebo (ECCO 2000) completed 12/99; preliminary results show no benefit in primary endpoint. FDA New Drug Application submitted 12/97, withdrawn 4/98.
Trial(s)


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