Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism
Centre Hospitalier Universitaire, Amiens
Phase 2/Phase 3
Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in
severe botulinic poisoning in measuring the effect on electrophysiological and respiratory
Study the natural history of electrophysiological and respiratory parameters during the
Clinical, electrophysiological and respiratory before and after administration of
Pilot study, prospective, interventional.
Case series (n = 8 patients) suffering from botulinic type A, respiratory failure, but with
no other organ failure
Experimental treatment :
3,4-diaminopyridine, FIRDAPSE ® (BioMarin) The dosage will be gradually increased according
to a predetermined scheme and will not exceed 60 mg / day and 20 mg / dose.
Intra-individual comparison of physiological parameters measured before and after
administration of 3,4-diaminopyridine. Electromyographic and respiratory parameters will be
measured for each patient. Then a dose of 10 mg of 3,4-diaminopyridine will be
administrated. If this dose is well tolerated and provides a relative improvement of 10% for
at least one of the parameters studied, the dose will be maintained at 10 mg for 48 hours 3
times a day then increased to 20 mg.
The primary endpoint is the change in the amplitude of muscle response evaluated by the
subtraction of amplitude at T1.5 and T0.
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