Trial of Oxaloacetate in ALS (TOALS)
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|ClinicalTrials.gov Identifier: NCT04204889|
Recruitment Status : Recruiting
First Posted : December 19, 2019
Last Update Posted : December 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|ALS||Drug: Oxaloacetic Acid||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trial of Oxaloacetate in ALS|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||February 2021|
3+3 dose escalating trial starting with 500mg twice daily orally and ending with 2500mg twice daily.
Drug: Oxaloacetic Acid
The first 3 patients will receive 500 mg twice daily, and subsequent cohorts will increase by 500 mg per dose to a maximum of 2500 mg twice daily.
Other Name: Oxaloacetate
- Dose limiting toxicities (DLT) [ Time Frame: Day 28 ]Defined as any serious adverse event related to OAA requiring hospitalization, or any AE related to OAA requiring stopping the medication, inculding a two fold increase in AST and/or LAT and /or a 1.5 times increase in creatinine level.
- Pharmacokinetic testing [ Time Frame: Day 28 ]OAA Levels
- Mitochondrial Biomarkers [ Time Frame: Day 28 ]Annexin V/Mitotracker in lymphocytes: assess modification of apoptosis/mitochondrial number. TMRE: Mitochondrial membrane potential. MitoSox: Mitochondrial superoxide. Glutamate-plasma: OAA specific biomarker.
- Platelet Biomarker [ Time Frame: Day 28 ]The levels of Serum TDP43
- MR spectroscopy [ Time Frame: Day 28 ]MR spectroscopy of brain glutathione
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204889
|Contact: Laura Herbelinemail@example.com|
|Contact: Collin Gerringerfirstname.lastname@example.org|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Omar Jawdat, MD||University of Kansas Medical Center|