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    The value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus Genetics related topics: Friedreich ataxia MedlinePlus related topics: Friedreich Ataxia Genetic and Rare Diseases Information Center resources: Friedreich Ataxia Spinocerebellar Ataxia FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Quadruple ( Participant Care Provider Investigator Outcomes Assessor ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : CTI-1601 Biological : CTI-1601 CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia Placebo Comparator : Placebo Biological : Placebo Placebo Comparator Primary Outcome Measures Outcome Measure Measure Description Time Frame Number of Participants with Treatment-Emergent Adverse Events Overall summary of the Participants with Treatment Emergent Adverse Events Through study completion, an average of 70 days Number of Treatment Emergent Adverse Events by System Organ Classification and Preferred Term Overall summary of Participants with Treatment Emergent Adverse Events by System Organ Classification (MedDRA version 22.0) Through study completion, an average of 70 days Secondary Outcome Measures Outcome Measure Measure Description Time Frame Pharmacokinetics - Area under the concentration-time curve after a single dose Summary assessment of changes in the area under the concentration-time curve after a single dose Up to 48 hours Pharmacokinetics - Maximum observed plasma concentration after a single dose Summary assessment of changes in the maximum observed plasma concentration after a single dose Up to 48 hours Pharmacokinetics - Time to reach maximum plasma concentration after a single dose Summary assessment of changes in time to reach maximum plasma concentration after a single dose Up to 48 hours Pharmacokinetics - Area under the concentration-time curve from time 0 to infinity Summary assessment of changes in the area under the concentration-time curve from time 0 to infinity 48 hours Pharmacokinetics - Area under the concentration-time curve from time 0 to the last measurable time point Summary assessment of changes in the Area under the concentration-time curve from time 0 to the last measurable time point 48 hours Pharmacokinetics - Apparent total plasma clearance Summary assessment of changes in the apparent total plasma clearance 48 hours Pharmacokinetics - Terminal half-life estimation Summary assessment of changes in the terminal half-life estimation 48 hours Pharmacokinetics - Apparent volume of distribution Summary assessment of changes in the apparent volume of distribution 48 hours Changes from Baseline in Frataxin Levels in Buccal Cells Summary assessment of changes in frataxin levels in buccal cells At baseline and up to 10 days Changes from Baseline in Frataxin Levels in Whole Blood Summary assessment of changes in frataxin levels in whole blood At baseline and up to 10 days Changes in Gene Expression Profiling Summary assessment of changes in gene expression levels At baseline and up to 10 days Additional Relevant MeSH Terms Dyskinesias Neurologic Manifestations Nervous System Diseases Cerebellar Diseases Brain Diseases Central Nervous System Diseases Spinocerebellar Degenerations Spinal Cord Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Mitochondrial Diseases Metabolic Diseases Ataxia Cerebellar Ataxia Friedreich Ataxia Studies a U.S. FDA-Regulated Drug Product Yes Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by Larimar Therapeutics, Inc. Friedreich's Ataxia Research Alliance Revision: v2.9.1.'
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