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Levocarnitine (Levocarnitine) - Summary

 



LEVOCARNITINE SUMMARY

LEVOCARNITINE INJECTION USP

Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane. Levocarnitine Injection USP is a sterile aqueous solution containing 1 g of levocarnitine per 5 mL vial. The pH is adjusted to 6.0 to 6.5 with hydrochloric acid.

Levocarnitine (levocarnitine) is indicated for the following:

For the acute and chronic treatment of patients with an inborn error of metabolism that results in secondary carnitine deficiency.


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NEWS HIGHLIGHTS

Clinical Trials Related to Levocarnitine

Levocarnitine in Treating Fatigue in Cancer Patients [Completed]
RATIONALE: Levocarnitine may help improve energy levels in cancer patients.

PURPOSE: This randomized phase III trial is studying how well levocarnitine works compared to a placebo in treating fatigue in cancer patients.

Valproic Acid and Carnitine in Patients With Spinal Muscular Atrophy [Completed]
This is a multi-center trial to assess safety and efficacy of a combined regimen of oral valproic acid (VPA) and carnitine in patients with Spinal Muscular Atrophy (SMA) 2 to 17 years of age. Cohort 1 is a double-blind placebo-controlled randomized intention to treat

protocol for SMA "sitters" 2 - 8 years of age. Cohort 2 is an open label protocol for SMA

"standers and walkers" 3 - 17 years of age to explore responsiveness of efficacy outcomes.

Outcome measures will include blood chemistries, functional testing, pulmonary function testing, electrophysiological evaluations, PedsQL quality of life assessment, quantitative assessments of survival motor neuron (SMN) mRNA from blood samples, growth and vital sign parameters. Six centers will enroll a total of 90 patients.

Evaluation of Cilostazol in Combination With L-Carnitine [Recruiting]
The purpose of this study is to see how safe and effective L carnitine taken with cilostazol is compared to placebo taken with cilostazol for people with intermittent claudication. A second purpose of the study is to see if L-carnitine is absorbed into the blood stream.

Ability of L-carnitine to Prevent Heart Damage in Breast Cancer Patients Receiving Anthracycline Chemotherapy [Recruiting]
Breast cancer is very common and afflicts 1 in 9 North American women. The treatment of breast cancer often requires the use of chemotherapy including "anthracyclines". Anthracyclines can damage the heart resulting in heart failure and even death. Clinicians and researchers are continually seeking methods that will reduce the toxic effects of anthracycline treatment.

L-carnitine is a substance that is produced naturally in the body and is required for normal heart function. Animal studies have suggested that L-carnitine protects the heart from the effects of anthracyclines, however this has not been verified in humans.

This study will assess the potential role of L-carnitine in the prevention of anthracycline induced heart damage. The investigators will enroll 144 patients into this study. Patients will be randomly assigned to L-carnitine therapy or to standard care (no L-carnitine therapy). Patients in the L-carnitine group will receive oral and intravenous L-carnitine prior to and after their anthracycline therapy. Patients will undergo regular follow up and testing to assess heart function. The investigators believe that patients treated with L-carnitine will benefit and have fewer complications associated with anthracycline treatment.

Early Administration of L-Carnitine in Hemodialysis Patients [Recruiting]
Hemodialysis is a cause of carnitine deficiency. The deficiency of carnitine induces an anemia by an increase fragility of the red blood cells, a muscular fatigue and a cardiac dysfunction. We proposed to evaluate the benefit of an early administration of L-carnitine in hemodialysis patients. The patients should be included in the first month after the start of chronic hemodialysis, randomized to receive L-carnitine or placebo and should be followed-up during one year.

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Page last updated: 2006-10-18

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