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. |
| NCT05123053 ↗ | Firdapse for Post-BOTOX Vocal Weakness | Recruiting | Augusta University | Phase 2 | 2021-10-28 | Botox injections into the thyroarytenoid muscle are a predictable and effective treatment for SD, but typically result in transient symptoms of voice weakness and breathiness during the first 2-3 weeks after injection. We hypothesize that voice weakness and breathiness after Botox treatment can be alleviated using amifampridine. |
| NCT05769478 ↗ | Effect of Amifampridine on Neuromuscular Transmission in Patients Treated With OnabotulinumtoxinA | Not yet recruiting | Wake Forest University Health Sciences | Phase 1 | 2023-04-01 | if amifampridine can improve neuromuscular transmission in muscles previously injected with OnabotulinumtoxinA (BTX-A) |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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