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NCT01016522 · ClinicalTrials.gov registry record · Phase 3

Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

A Phase 3 study, sponsored by Johns Hopkins University.

Terminated
Registry status
Phase 3
Development phase
1
Enrollment target

NCT01016522: Clinical Trial Phase 3 study, sponsored by Johns Hopkins University.

NCT01016522 is a Phase 3 study that was terminated before completion, run by Johns Hopkins University. The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01016522, a Phase 3 study, was terminated before completion, sponsored by Johns Hopkins University.

TERMINATED
Registry status
Phase 3
Development phase
1 participants
Enrollment target

Study Summary

This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.

Interventions

  • DIETARY_SUPPLEMENT KetoCal

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2009-11
Est. Completion 2012-01
Phase Phase 3

Sponsor

Johns Hopkins University

1,448 total trials

What the Registry Record Tells You About NCT01016522

The ClinicalTrials.gov registry entry for NCT01016522 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.

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

NCT01016522 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01016522 about?

NCT01016522 is a clinical study titled "Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)". This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.

What is the current status of trial NCT01016522?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2009-11. Estimated completion is 2012-01.

What interventions are being tested in trial NCT01016522?

The interventions under investigation include: KetoCal (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01016522?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.