Botulism Clinical Trial
Official title:
Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | March 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - botulism - ventilation Exclusion Criteria: - renal failure - cardiac failure - pregnancy - under age 18 - hepatic failure |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | CHU | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | electrophysiological | Primary endpoint: Clinical, electrophysiological and respiratory before and after administration of 3,4-diaminopyridine. |
90 min | No |
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