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NCT02716662 · ClinicalTrials.gov registry record · NA

Safety of Caprylic Triglycerides in ALS: A Pilot Study

A NA study, sponsored by Weill Medical College of Cornell University.

Completed
Registry status
NA
Development phase
10
Enrollment target

NCT02716662 is a NA study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 10 participants.

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The verdict

NCT02716662, a NA study, has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
NA
Development phase
10 participants
Enrollment target

Study 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_SUPPLEMENT Axona

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2016-01-01
Est. Completion 2018-04-25
Phase NA

What the Registry Record Tells You About NCT02716662

The ClinicalTrials.gov registry entry for NCT02716662 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Axona is the first listed.

NCT02716662 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02716662 about?

NCT02716662 is a clinical study titled "Safety of Caprylic Triglycerides in ALS: A Pilot Study". 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,...

What is the current status of trial NCT02716662?

This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2016-01-01. Estimated completion is 2018-04-25.

What interventions are being tested in trial NCT02716662?

The interventions under investigation include: Axona (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT02716662?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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