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NCT01797276 Clinical Trial

Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Mitochondrial Enzyme Deficiencies Clinical Trial

— CLA  

Official title:
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01797276
Other study ID # IRB#420-2005
Secondary ID
Status No longer available
Phase N/A
First received February 15, 2013
Last updated August 7, 2017

Study information
Verified date August 2017
Source University of Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Diagnosis of congenital lactic acidosis

- Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis Exclusion Criteria:

- Intolerance to DCA

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dichloroacetate
Subjects are given DCA 25mg/kg in a divided dose twice a day.

Locations
Country Name City State
United States University of Florida Box 100226 Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
University of Florida

Country where clinical trial is conducted

United States,