anyone know of this nootropic?
increased alertness, anti-fatigue?
Double-blind, randomized, placebo controlled study of the effects on wake EEG of 2 doses of praxileneâ using a cross-over design in elderly healthy male volunteers
Boeijinga P.H, Muzet M, Gamand S.a), d’Aniello F, Luthringer R, Macher J-P
FORENAP, Centre Hospitalier, 68250 ROUFFACH, France
a) LIPHA SA, 69379 LYON, France
European Neuropsychopharmacology, 2001, 10 (Suppl. 3); S363
Aims : To evaluate the dose-dependency of CNS pharmacodynamic effects after single and repeated administration of Praxilene® (naftidrofuryl) as assessed by objective electrophysiological techniques in elderly healthy subjects during waking, and to characterize the pharmaco-EEG profile of Praxilene®.
Methods : Monocentric, double-blind randomized, placebo controlled study comparing two repeated doses of Praxilene® versus placebo, using a cross-over design in 12 healhy volunteers aged between 55-70 years. Doses of 400 and 600 mg/day of Praxilene® or its placebo were administered from Day1 to Day5.
EEG recordings were obtained under conditions of maintained vigilance and rest.
A montage of 28 active electrodes referenced to linked ears has been used. Frequency band parameters (absolute as well as relative measures) were extracted from FFT-spectra and subjected to non-parametric statistical analysis and topographic mapping. Subjects were asked to perform an auditory CNV paradigm as well; the task consisted in pressing immediately a response button when a test-tone (750 Hz), which followed 1.5 sec after a warning stimulus (1 kHz), was presented.
Results : After single administration of Praxilene® differences compared to placebo are observed already at 1 hour postdosing and can remain until 2-4h; they can be characterized by an increase in theta rhythm and decreases of energy in the alpha-1 and slow beta frequency bands for both doses. For the dose of 400mg in addition increases in delta energy have been observed. For both doses CNV responses were enhanced at 1h postdosing.
After administration on Day 5, superimposed on repeated administration, a general amplification of effects for both doses have occurred 2h in alpha-2, slow beta; additionally fast beta is diminished and the decreases lead to modifications in total spectral energy in frontal scalp regions. Mainly for the dose of 400 mg, however, additional systematic modifications have been obsered at 7h, namely an increase in the alpha-1(temporal scalp regions) and alpha-2 (in frontal scalp regions only) frequency bands. Before treatment on Day 5, CNV responses were slightly enhanced for the dose of 600 mg only.
After repeated oral doses of 400mg and 600mg of Praxilene® only nine adverse events have occurred (in five out of 12 subjects). All these adverse events were of mild or moderate intensity. No significant changes in vital signs, biological and electrocardiographic parameters were observed.
Conclusion: The results of the present study show that 400mg and 600mg of Praxilene® induces a desynchronisation of the EEG in the elderly, which can be interpreted at the neurophysiological level as an increased alerting level.The prevention of increases in beta energy, which is seen normally under placebo, as well as the acute CNV effects point to improved vigilance and attention and suggest that Praxilene® protects against fatigue phenomena, presumably due to an original mechanism of action combining direct rheological modifications with affinity for CNS serotoninergic pathways.
The detailed interpretation of observed effects and the profile of Praxilene® will be discussed in relation to functional aspects of energetic demands and will be compared to other nootropic compounds.
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