NCT01797276

Brief Summary

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

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

First QC Date

February 15, 2013

Last Update Submit

August 7, 2017

Conditions

Keywords

Dichloroacetate (DCA)Congenital Lactic Acidosis (CLA)acidosisorphan disease

Interventions

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

Also known as: DCA

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of congenital lactic acidosis

You may not qualify if:

  • Intolerance to DCA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Box 100226

Gainesville, Florida, 32610-0226, United States

Location

MeSH Terms

Conditions

AcidosisRare Diseases

Interventions

Dichloroacetic Acid

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloroacetatesAcetatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydrocarbons, ChlorinatedHydrocarbons, HalogenatedHydrocarbons

Study Officials

  • Peter W. Stacpoole, PhD, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

February 22, 2013

Last Updated

August 8, 2017

Record last verified: 2017-08

Locations