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Last Updated: July 31, 2021

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CLINICAL TRIALS PROFILE FOR FIRDAPSE

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All Clinical Trials for FIRDAPSE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01441557 ↗ Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism Completed Centre Hospitalier Universitaire, Amiens Phase 2/Phase 3 2011-09-01 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FIRDAPSE

Condition Name

Condition Name for FIRDAPSE
Intervention Trials
Botulism 1
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Condition MeSH

Condition MeSH for FIRDAPSE
Intervention Trials
Botulism 1
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Clinical Trial Locations for FIRDAPSE

Trials by Country

Trials by Country for FIRDAPSE
Location Trials
France 1
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Clinical Trial Progress for FIRDAPSE

Clinical Trial Phase

Clinical Trial Phase for FIRDAPSE
Clinical Trial Phase Trials
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for FIRDAPSE
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for FIRDAPSE

Sponsor Name

Sponsor Name for FIRDAPSE
Sponsor Trials
Centre Hospitalier Universitaire, Amiens 1
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Sponsor Type

Sponsor Type for FIRDAPSE
Sponsor Trials
Other 1
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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
McKesson
Boehringer Ingelheim
Harvard Business School
Colorcon

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