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Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism

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ClinicalTrials.gov Identifier: NCT01441557
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : April 28, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Botulism Drug: 3,4-diaminopyridine Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botulism
U.S. FDA Resources


Intervention Details:
    Drug: 3,4-diaminopyridine
    test dose 10 mg then 20 mg, then depending on tolerance and efficacy full-dose administration(from 10mg /8h to 20 mg /8h)


Primary Outcome Measures :
  1. electrophysiological [ Time Frame: 90 min ]

    Primary endpoint:

    Clinical, electrophysiological and respiratory before and after administration of 3,4-diaminopyridine.




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • botulism
  • ventilation

Exclusion Criteria:

  • renal failure
  • cardiac failure
  • pregnancy
  • under age 18
  • hepatic failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441557


Locations
France
CHU
Amiens, France, 80000
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Herve DUPONT, Md, PhD CHU Amiens

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01441557     History of Changes
Other Study ID Numbers: PI11-PR-DUPONT
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: April 28, 2016
Last Verified: April 2016

Keywords provided by Centre Hospitalier Universitaire, Amiens:
mechanical ventilation

Additional relevant MeSH terms:
Botulism
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Junction Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurotoxicity Syndromes
Foodborne Diseases
Poisoning
Chemically-Induced Disorders
3,4-diaminopyridine
4-Aminopyridine
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action