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Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency: (DCA/PDCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02616484
Recruitment Status : Recruiting
First Posted : November 30, 2015
Last Update Posted : February 19, 2020
Columbia University
Medosome Biotec LLC
Saol Therapeutics
Information provided by (Responsible Party):
University of Florida

No Study Results Posted on for this Study
Recruitment Status : Recruiting
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : March 30, 2023
Henderson GH, Whalen PO, Darr RA, Curry SH, Derendorf H, Baumgartner TG, Stacpoole PW: Development of an oral drug formulation for dichloroacetate and thiamine. Drug Devel Indust Pharm, 20:2425-2437, 1994.
Robinson BH. Lactic academia (disorders of pyruvate carboxylase, pyruvate dehydrogenase). In: Scriver CR, Beaudet AL, Sly WS, Valle D. (Eds.). The metabolic and molecular bases of inherited disease, seventh ed. McGraw-Hill, New York, pp. 1479-1499, 1995.
Papadopoulos EJ, Patrick DL, Tassinari MS, Mulberg AE, Epps C, Pariser AR, Burke LB. Clinical outcome assessments for clinical trials in children. In Pediatric Drug Development: Concepts and Applications (Eds. AE Mulberg, D Murphy, J Dunne and LL Mathis. John Wiley & Sons, Ltd, Hoboken, NJ, pp. 539-548.
Lehman, EL. Nonparametrics: Statistical methods Based on Ranks. (Page 173). Holden-Day, San Francisco, 1975.