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Generated: December 19, 2018

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CLINICAL TRIALS PROFILE FOR LEVOCARNITINE

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Clinical Trials for Levocarnitine

Trial ID Title Status Sponsor Phase Summary
NCT00079599 L-Carnitine to Treat Fatigue in AIDS Patients Completed National Institute of Nursing Research (NINR) Phase 2 Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients. This study will determine whether carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient patients with AIDS.
NCT00822172 Evaluation of Cilostazol in Combination With L-Carnitine Completed Otsuka Pharmaceutical Co., Ltd. Phase 4 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.
NCT00822172 Evaluation of Cilostazol in Combination With L-Carnitine Completed Colorado Prevention Center Phase 4 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.
NCT01671384 Valproate and Levocarnitine in Children With Spinal Muscular Atrophy Recruiting All India Institute of Medical Sciences, New Delhi Phase 3 Spinal muscular atrophy (SMA), an autosomal recessive disorder, is characterized by muscle weakness due to degeneration of anterior horn cells in the spinal cord and brain stem nuclei. It has a variable incidence of 1 in 6700 to 1 in 25000 live births and prevalence of 0.12 to 25 per 10,000 populations in different geographic areas and genetic constitution. A homozygous deletion/mutation involving exon 7 in SMN1 (survival motor neuron 1) is present in around 95% of the cases, resulting in the biochemical deficiency of the SMN protein. A genomic duplication at the same locus produces nearly identical SMN2 (survival motor neuron 2) that differs from SMN1 by a nucleotide substitution that promotes exon 7 exclusion thus giving rise to only a fraction of the full length protein. Phenotypic variation in SMA correlates with the number of SMN2 gene copies and the level of SMN protein in cells. Several hypotheses including defective inhibition of apoptosis, glutamate excitotoxicity and lack of a neurotrophic factor(s) in nerve or muscle have been speculated in the pathogenesis of SMA. Valproic acid (VPA), a histone deacetylase (HDAC) inhibitor, directly increases SMN expression in SMA patient-derived cell lines in vitro. Till date 3 open label trials and 1 placebo controlled RCT of VPA in human subjects have been published, all indicating a possible benefit in strength and/or motor function. Till date there is no effective therapy for SMA. Therapy is mainly supportive and palliative which can prolong lifespan and prevent complications to some extent without actually curing the disease. Children with SMA may have a reduced capacity to synthesis carnitine consequent to significantly diminished skeletal muscle mass. VPA independently inhibits carnitine transport and its metabolites deplete carnitine levels by binding to them. So along with valproate these patients should be supplemented with carnitine. With this background the investigators have planned a double blind randomized placebo controlled trial of Valproate and levocarnitine in 60 children (30 each in intervention and control arm) with Spinal Muscular Atrophy aged 2-15 years over a 2 year period with one baseline and four follow up visits. The study will be conducted in the Department of Pediatrics, AIIMS at the Myopathy clinic.
NCT01783041 Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants Recruiting The Gerber Foundation Phase 2/Phase 3 Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.
NCT01783041 Effect of Early L-Carnitine Supplementation on Neurodevelopmental Outcomes in Very Preterm Infants Recruiting Montefiore Medical Center Phase 2/Phase 3 Preterm infants are vulnerable to brain injury, nutritional deficiencies and poor early growth which places them at increased risk for developmental problems later in life. The micronutrient carnitine, which is present in breast milk and stored in the fetus late in pregnancy, has been shown to protect against brain injury in animal studies. Without supplementation, almost all preterm infants develop carnitine deficiency soon after birth. Thus it is important to determine if carnitine supplementation protects against brain injury and improves developmental outcomes in these vulnerable preterm infants. We hypothesize that preterm infants supplemented early with L-carnitine while receiving parenteral nutrition will not develop carnitine deficiency and will have improved growth in the first two weeks of life and higher scores on developmental tests when compared to control infants who did not receive carnitine.
NCT02348125 Does Clinical Treatment of Mitochondrial Dysfunction Impact Autism Spectrum Disorder (ASD)? Recruiting Drexel University Phase 1 In this study, 50 children between 3 and 12 years old with formally diagnosed autistic spectrum disorders (ASD) and also having significant mitochondrial dysfunction will be treated for a 3 month period with the Mitochondrial Cocktail, a combination of specific nutritional supplements and metabolite intermediates (including anti-oxidants) and bio-energy substrates. A series of neurological and psychological evaluations will be conducted by trained evaluators/clinicians to evaluate both the severity and the clinical presentation of the ASD/mitochondrial dysfunction with each subject at baseline prior to treatment, after the 3 month treatment and again at 6 months, after another 3 month non-treatment period. In addition, laboratory investigations will be conducted at the same time-points to assess the mitochondrial dysfunction and cellular biomarkers thought to be associated with autistic and mitochondrial disorders. These investigations will include the analysis of samples of blood and cheek/buccal swabs collected from each child to assess select biochemical markers of ASD. The Mitochondrial Cocktail treatment will be administered at home once a day continuously for a total of 3 months. All the children in the study will be treated with the same Mitochondrial Cocktail (an open label study).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Levocarnitine

Condition Name

Condition Name for Levocarnitine
Intervention Trials
Carnitine Deficiency 1
Peripheral Vascular Disease 1
Body Weight Changes 1
Peripheral Arterial Disease 1
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Condition MeSH

Condition MeSH for Levocarnitine
Intervention Trials
Autistic Disorder 1
Hyperbilirubinemia 1
Vascular Diseases 1
Autism Spectrum Disorder 1
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Clinical Trial Locations for Levocarnitine

Trials by Country

Trials by Country for Levocarnitine
Location Trials
United States 19
Mexico 1
India 1
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Trials by US State

Trials by US State for Levocarnitine
Location Trials
New York 3
Texas 2
Pennsylvania 1
Wisconsin 1
Utah 1
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Clinical Trial Progress for Levocarnitine

Clinical Trial Phase

Clinical Trial Phase for Levocarnitine
Clinical Trial Phase Trials
Phase 4 1
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Levocarnitine
Clinical Trial Phase Trials
Recruiting 4
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for Levocarnitine

Sponsor Name

Sponsor Name for Levocarnitine
Sponsor Trials
Montefiore Medical Center 1
The Gerber Foundation 1
All India Institute of Medical Sciences, New Delhi 1
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Sponsor Type

Sponsor Type for Levocarnitine
Sponsor Trials
Other 7
Industry 1
NIH 1
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