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Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT01797276
Acronym
CLA
Enrollment
Unknown
Registered
2013-02-22
Start date
Unknown
Completion date
Unknown
Last updated
2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitochondrial Enzyme Deficiencies

Keywords

Dichloroacetate (DCA), Congenital Lactic Acidosis (CLA), acidosis, orphan disease

Brief summary

Expanded access to DCA as continued treatment for congenital lactic acidosis.

Detailed description

Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access. Study participants must travel to the study site for bi-annual evaluation by the study investigator. Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated).

Interventions

DRUGDichloroacetate

Subjects are given DCA 25mg/kg in a divided dose twice a day.

Sponsors

University of Florida
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of congenital lactic acidosis * Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis

Exclusion criteria

* Intolerance to DCA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026