Trial of Oxaloacetate in ALS
TOALS
Trial of Oxaloacetate in Amyotrophic Lateral Sclerosis
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to determine the safety and the maximal tolerated dose of Oxaloacetate (OAA) in patients with Amyotrophic Lateral Sclerosis (ALS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2020
Typical duration for phase_1
1 active site
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
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
December 19, 2019
CompletedStudy Start
First participant enrolled
March 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2023
CompletedJune 6, 2024
June 1, 2024
3.4 years
December 17, 2019
June 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Dose limiting toxicities (DLT)
Defined as any serious adverse event related to OAA requiring hospitalization, or any AE related to OAA requiring stopping the medication, including a two fold increase in AST and/or LAT and /or a 1.5 times increase in creatinine level.
Day 28
Secondary Outcomes (4)
Pharmacokinetic testing
Day 28
Mitochondrial Biomarkers
Day 28
Platelet Biomarker
Day 28
MR spectroscopy
Day 28
Study Arms (1)
Oxaloacetate
EXPERIMENTAL3+3 dose escalating trial starting with 500mg twice daily orally and ending with 2500mg twice daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- A clinical diagnosis by a study investigator of laboratory-supported probable, probable, or definite ALS, according to the modified El Escorial criteria\[1\]
- Vital capacity (VC) greater or equal to 50% of predicted
- Diagnosis with ALS within 3 years prior to enrollment
- If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit
- Women of childbearing age must use protection against pregnancy.
You may not qualify if:
- Requirement for tracheotomy ventilation or non-invasive ventilation for \> 23 hours per day
- Diagnosis of other neurodegenerative diseases (e.g., Parkinson disease, Alzheimer disease)
- Clinically significant history of unstable medical illness (e.g., unstable angina, advanced cancer) over the last 30 days
- Current pregnancy or lactation
- Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures
- Receipt of any investigational drug within the past 30 days from enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Omar Jawdatlead
- Terra Biological LLCcollaborator
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Jawdat, MD
University of Kansas Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 17, 2019
First Posted
December 19, 2019
Study Start
March 17, 2020
Primary Completion
August 2, 2023
Study Completion
August 2, 2023
Last Updated
June 6, 2024
Record last verified: 2024-06