Main objectives: Evaluate the effectiveness of an administration of 3,4-diaminopyridine (FIRDAPSE ®) in severe botulinic poisoning in measuring the effect on electrophysiological and respiratory parameters Secondary Objective: Study the natural history of electrophysiological and respiratory parameters during the botulinic intoxication Primary endpoint: Clinical, electrophysiological and respiratory before and after administration of 3,4-diaminopyridine. Study Design: Pilot study, prospective, interventional. Study population: 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. Statistics: 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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
electrophysiological
Timeframe: 90 min