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We list hundreds of Clinical Trials about "Catalyst Pharmaceuticals Firdapse garners approval Lambert Eaton myasthenic" on BioPortfolio. We draw our references from global clinical trials data listed on ClinicalTrials.gov and refresh our database daily.
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Compassionate use of orphan drug 3,4-Diaminopyridine (DAP) in Treatment of Lambert Eaton Myasthenic Syndrome (LEMS). The purpose of the use of this drug is to decrease the weakness associated with Lambert -Eaton Myasthenic Syndrome, and hopefully decrease the need for prednisone, and other therapies previously required to control your symptoms. The duration of the use of this drug will depend upon whether you see benefit from it, and whether any side effects from the drug pre...
OBJECTIVES: I. Evaluate the safety and effectiveness of 3,4-diaminopyridine (DAP) in the treatment of patients with Lambert-Eaton myasthenic syndrome (LEMS). II. Determine the side-effects and benefits associated with DAP.
The purpose of this study is to determine the effectiveness and adverse effects of 3,4-diaminopyridine for the treatment of the Lambert-Eaton Myasthenic Syndrome (LEMS).
The purpose of the study is to provide expanded access (compassionate use) of 3,4 diaminopyridine to patients with Lambert-Eaton myasthenic syndrome (LEMS).
This study evaluates the effect of withdrawing amifampridine phosphate treatment from patients with LEMS. One half of the patients will continue to receive amifampridine phosphate and the other half will receive placebo, during this double-blind study.
Congenital myasthenia and LEMS are potentially lethal disorder, which, even with careful management, significantly impedes participation in normal daily functions. Currently approved therapies have had little impact on promoting a normal quality of life activity in these patients. Our hope is to systematically examine the effect of 3,4-DAP on the natural course of this disease and to gain additional experience in titrating 3,4-DAP with other available therapies to maximize clin...
A new drug called 3,4-Diaminopyridine (3,4-DAP) is currently under investigation for treatment of the symptoms of Lambert-Eaton Myasthenic Syndrome. This is an expanded access trial, which means that although data from this study will be collected and reported to the US Food and Drug Administration (FDA)and the drug manufacturer, this is not a formal study of drug in Lambert-Eaton Syndrome. If you decide to volunteer, you will be evaluated by a neurologist to determine your ...
Upper respiratory infection , including influenza, may exacerbate the symptoms of myasthenia gravis (MG), which is an autoimmune disease that causes muscle weakness and, in some cases, can precipitate a myasthenic crisis In the present study, we investigated the incidence and risk factors of influenza infection on in myasthenia gravis patients.
This randomized, double-blind, controlled, outpatient two-period, two-treatment crossover study is designed to evaluate the efficacy and safety of amifampridine phosphate in patients (ages 2 to 17) diagnosed with certain genetic subtypes of CMS and demonstrated open label (amifampridine phosphate) or history of sustained amifampridine benefit from treatment.
This study compared the relative bioavailability (rate and extent of absorption) of Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers under non-fasting conditions.
This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.
1. Introduction: Investigators think that surgery with preservation of healthy joints (hemitrapeziectomy) in trapeziometacarpal osteoarthritis without affecting sapho-trapezo-trapezoid joints, is better for scaphoid stability by preventing its collapse and thus preserving the stability of the carpus. 2. Objectives and Hypothesis: Ligamentoplasty with partial trapeziectomy in grades II-III Eaton presents better results in the pollic...
Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic®20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
Subjects to compare the single dose bioavailability of Torrent's Nebivolol Tablets 20 mg and Bystolic 20 mg Tablets of Forest Pharmaceuticals Inc., USA. Dosing periods of studies were separated by a washout period of 11 days.
MYASTHENIA GRAVIS (MG) is an autoimmune disease characterized by varying degrees of muscle weakness and fatigability worsened with exertion and relieved with rest。Thymectomy plays an important role in the management of these patients because a consistent association between myasthenic and thymic pathology has been recognized.The need for prolonged mechanical ventilation in these patients after thymectomy is determined by their preoperative condition and various perioperative ...
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in Fed Condition
- Objective: - The objective of this study is to compare the rate and extent of absorption of the Test Product, Citalopram Hydrobromide 40 mg (Torrent Pharmaceutical Limited) to the Reference Product, RLD Tablets 40 mg (Forest Pharmaceuticals Inc, Missouri) under fed condition - Study Design: - Randomized, Single Dose, Open Label, Non-Replicate, Two-period, Two-treatment, Two- Sequence Crossover Bioequiv...
Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of studies were separated by a washout period of 7 days.
This study will compare the relative bioavailability (rate and extent of absorption) of 50 mg Cilostazol Tablets manufactured by TEVA Pharmaceuticals Industries Ltd. and distributed by TEVA Pharmaceuticals USA with that of PLETAL Tablets manufactured by Otsuka Pharmaceuticals Co., Ltd. for Otsuka America Pharmaceutical, Inc. following a single oral dose (1 x 50 mg tablet) in healthy adult subjects administered under fasting conditions.
The purpose of the Post Approval Study of the ABC and Trident systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.
Bradmer Pharmaceuticals, Inc. (Bradmer) is requesting approval to study the safety of Neuradiab® when combined with Bevacizumab (Avastin) therapy given at a minimum of 30 days after Neuradiab administration in patients with a first or second recurrence of glioblastoma multiforme (GBM), in an attempt to manage life threatening recurrence of Grade IV malignant glioma.
The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).
Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Under Fasting Condition
- Objective: - To compare the rate and extent of absorption of Citalopram Hydrobromide Tablets 40 mg: Test Product: Citalopram Hydrobromide Tablets 40 mg manufactured by Torrent Pharmaceuticals Limited, India Reference Product: CelexaTM Tablets 40 mg (Reference Listed Drug) manufactured by Forest Pharmaceuticals Inc., Missouri under fasting conditions in 36 healthy, adult, human subjects in a randomized crossover...
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of ...
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW(-S) BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.