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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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-11 |
| Est. Completion | 2012-01 |
| Phase | Phase 3 |
Why NCT01016522 stopped before completion
NCT01016522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 1 intervention - of which KetoCal is the first listed.
NCT01016522 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01016522's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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