Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Botulism |
Drug: 3,4-diaminopyridine |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Pilot Study on the Usefulness of 3,4-diaminopyridine in the Treatment of Botulism |
- electrophysiological [ Time Frame: 90 min ] [ Designated as safety issue: No ]
Primary endpoint:
Clinical, electrophysiological and respiratory before and after administration of 3,4-diaminopyridine.
| Enrollment: | 3 |
| Study Start Date: | September 2011 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
-
Drug: 3,4-diaminopyridine
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- botulism
- ventilation
Exclusion Criteria:
- renal failure
- cardiac failure
- pregnancy
- under age 18
- hepatic failure
Contacts and Locations More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire, Amiens |
| ClinicalTrials.gov Identifier: | NCT01441557 History of Changes |
| Other Study ID Numbers: | 2011-004656-19 |
| Study First Received: | September 26, 2011 |
| Last Updated: | June 22, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 |
Substance-Related Disorders 3,4-diaminopyridine 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013