Safety of Caprylic Triglycerides in ALS: A Pilot Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02716662

Enrollment

Registered

2016-03-23

Start date

2016-01-01

Completion date

2018-04-25

Last updated

2018-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALS

Brief summary

The purpose of this study is to determine if AC-1204 is safe and tolerated in subjects with ALS. The reason why the investigator wants to use AC-1204 in patients with ALS is to determine if, by taking AC-1204, the body will make substances called ketone bodies. Further, if AC-1204 is well tolerated, the investigators want to change the amount the participant takes, to determine if the amount of ketone bodies in the blood increase in accordance with increases in the amount of AC-1204 the participant takes. The investigators want to do this study because when the investigators gave AC-1204 to mice with ALS, findings suggest the disease course is altered for the better and that the cause of this change is due to the presence of ketones in the blood. If AC-1204 can be proven to be safe and able to cause ketones to increase in the blood, the investigators will likely do subsequent studies to determine if the presence of ketone bodies will slow or stop the progression of the disease. However, this study is not designed to determine if AC-1204 will stop or slow the progression of ALS. It is designed to only determine if patients with ALS can tolerate AC-1204, if ketone bodies are produced and if the amount of ketone bodies produced increases with increasing dose.

Interventions

DIETARY_SUPPLEMENTAxona

medical powder, supplement food

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria, * Age 18 or older, * Capable of providing informed consent and complying with trial procedures, * Appel ALS score less than 100, * Able to stand on a scale with assistance, * Willing to chart food intake during the 12 week study, * Patients either not taking Riluzole (Rilutek) or on a stable dose for 30 days or more, * Not taking Coenzyme Q10 or on a stable dose and brand for 30 days, * Absence of

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Ketone levels	4 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026