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NCT00004493 · ClinicalTrials.gov registry record · Phase 2

Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia

A Phase 2 study, sponsored by University of California, San Diego.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT00004493: Completed Phase 2 study, sponsored by University of California, San Diego.

NCT00004493 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00004493, a Phase 2 study, has completed, sponsored by University of California, San Diego.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developmental function, or slowing neurological or developmental deterioration in these patients.

Interventions

  • DRUG sodium dichloroacetate

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 1998-09
Est. Completion 2003-09
Phase Phase 2
University of California, San Diego

775 total trials

What the finished NCT00004493 record still lists

NCT00004493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which sodium dichloroacetate is the first listed.

NCT00004493 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00004493 about?

NCT00004493 is a clinical study titled "Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia". OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developm...

What is the current status of trial NCT00004493?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 1998-09. Estimated completion is 2003-09.

What interventions are being tested in trial NCT00004493?

The interventions under investigation include: sodium dichloroacetate (DRUG).

Who is sponsoring clinical trial NCT00004493?

This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00004493's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00004493, the US trial registry maintained by the National Library of Medicine. NCT00004493 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.