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CLA: Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Sponsor
University of Florida (Other)
Overall Status
No longer available
CT.gov ID
NCT01797276
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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).

Study Design

Study Type:
Expanded Access
Official Title:
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Box 100226 Gainesville Florida United States 32610-0226

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Peter W. Stacpoole, PhD, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT01797276
    Other Study ID Numbers:
    • IRB#420-2005
    First Posted:
    Feb 22, 2013
    Last Update Posted:
    Aug 8, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by University of Florida
    Dichloroacetate (DCA)
    Congenital Lactic Acidosis (CLA)
    acidosis
    orphan disease
    Additional relevant MeSH terms:
    Acidosis
    Acidosis, Lactic

    Study Results

    No Results Posted as of Aug 8, 2017