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Trial of Dichloroacetate in Pyruvate Dehydrogenase Complex Deficiency:

Study acronym: DCA/PDCD
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 4, 2025 (before its estimated August 27, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 9 to 10
    • Primary and study completion dates: Mar 30, 2025 to Aug 27, 2025
    • Study description expanded, about 3 words
    • Collaborators expanded, about 3 words
    v38
  2. Lead sponsor: University of Florida to Saol Therapeutics Inc
    • Collaborators shortened, about 15 words
    v37
  3. Collaborators: 3 to 2v36
  4. Re-verified, no change to tracked fieldsv35
  5. Collaborators: 4 to 3v34
Show 32 earlier versionsHide 32 earlier versions
  1. Re-verified, no change to tracked fieldsv33
  2. Primary completion date: Apr 30, 2023 to Mar 30, 2025
    • Study completion date: May 31, 2023 to Mar 30, 2025
    v32
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 12 to confirmed 34
    • Site details revised at 9 of 9 sites
    • Collaborators: 3 to 4
    v31
  4. Enrollment target: 9 to 12
    • Primary completion date: Jul 31, 2023 to Apr 30, 2023
    • Study completion date: Dec 30, 2023 to May 31, 2023
    • Site contacts updated at 1 of 9 sites
    v30
  5. 3 versions Re-verified since Jan 11, 2021, no change to tracked fieldsv27-v29
  6. Collaborators: 4 to 3v26
  7. Re-verified, no change to tracked fieldsv25
  8. Primary completion date: Dec 31, 2022 to Jul 31, 2023
    • Start date: Nov 1, 2019 to Jul 14, 2020
    • Study completion date: Mar 30, 2023 to Dec 30, 2023
    • Collaborators: 3 to 4
    v24
  9. Site details revised at 1 of 9 sitesv23
  10. Start date changed from estimate of Oct 1, 2019 to Nov 1, 2019v22
  11. Primary completion date: Dec 31, 2021 to Dec 31, 2022v21 Show 4 more changesShow less
    • Start date: Oct 1, 2017 to Oct 1, 2019
    • Study completion date: Mar 30, 2022 to Mar 30, 2023
    • Site contacts updated at 1 of 9 sites
    • Study description shortened, about 3 words
  12. Collaborators: 4 to 3v20
  13. Primary completion date: Jun 30, 2020 to Dec 31, 2021
    • Study completion date: Jun 30, 2020 to Mar 30, 2022
    v19
  14. Enrollment target: 30 to 9
    • Collaborators: 3 to 4
    v18
  15. Re-verified, no change to tracked fieldsv17
  16. Enrollment target: 9 to 30
    • Site details revised at 1 of 9 sites
    • Collaborators revised (3)
    v16
  17. Site contacts updated at 1 of 9 sitesv15
  18. Site details revised at 5 of 9 sitesv14
  19. Enrollment target: 30 to 9v13
  20. Enrollment target: 9 to 30
    • Study sites: 11 to 9
    • Study description expanded, about 48 words
    • Collaborators: 2 to 3
    v12
  21. Study sites: 9 to 11
    • Collaborators revised (2)
    v11
  22. Study sites revised (9)
    • Collaborators: 3 to 2
    v10
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 9
    • Collaborators: 2 to 3
    v9
  24. Start date: Jul 29, 2017 to Oct 1, 2017v8
  25. Start date: Apr 29, 2017 to Jul 29, 2017v7
  26. Re-verified, no change to tracked fieldsv6
  27. Enrollment target: 24 to 9v5 Show 6 more changesShow less
    • Study sites: 10 to 8
    • Primary and study completion dates: May 29, 2020 to Jun 30, 2020
    • Eligibility criteria shortened, about 32 words
    • Secondary endpoints revised (3)
    • Study description expanded, about 210 words
    • Collaborators: 3 to 2
  28. Start date: Feb 2017 to Apr 29, 2017
    • Primary and study completion dates: May 2020 to May 29, 2020
    v4
  29. Start date: Jun 2016 to Feb 2017v3
  30. Start date: Jan 2016 to Jun 2016
    • Primary and study completion dates: Dec 2020 to May 2020
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The objective of this research study is to conduct a pivotal phase 3 trial of treatment with the investigational drug dichloroacetate (DCA) in young children with deficiency of the pyruvate dehydrogenase complex (PDC). PDC deficiency (PDCD) is the most common cause of congenital lactic acidosis and is a frequently fatal metabolic disease of childhood for which no proven treatment exists. The investigators predict that DCA represents targeted potential therapy for PDCD because of its ability to increase both the catalytic activity and stability of the enzyme complex. The conclusions of numerous laboratory and clinical investigations are consistent with this postulate and have led to the designation of DCA as an Orphan Product for congenital lactic acidosis by the Food and Drug Administration. A novel Observer reported outcome (ObsRO) survey that is completed by study participant's parent/caregiver, is the efficacy outcome measure. Funding Source - FDA OOPD
Trial Details
NCT Number NCT02616484
Lead Sponsor Saol Therapeutics Inc
Collaborators: Medosome Biotec LLC
Conditions
(from sponsor)		 Pyruvate Dehydrogenase Complex Deficiency
Related terms Pyruvate Dehydrogenase Complex Deficiency Disease
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov