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NCT02030015 · ClinicalTrials.gov registry record · Phase 4
Synergistic Enteral Regimen for Treatment of the Gangliosidoses
A Phase 4 study, sponsored by University of Minnesota.
- Terminated
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT02030015: Clinical Trial Phase 4 study, sponsored by University of Minnesota.
NCT02030015 is a Phase 4 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02030015, a Phase 4 study, was terminated before completion, sponsored by University of Minnesota.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
The investigators hypothesize that a combination therapy using miglustat and the ketogenic diet for infantile and juvenile patients with gangliosidoses will create a synergy that 1) improves overall survival for patients with infantile or juvenile gangliosidoses, and 2) improves neurodevelopmental clinical outcomes of therapy, compared to data reported in previous natural history studies. The ketogenic diet is indicated for management of seizures in patients with seizure disorders. In this study, the ketogenic diet will be used to minimize or prevent gastrointestinal side-effects of miglustat. A Sandhoff disease mouse study has shown that the ketogenic diet may also improve central nervous system response to miglustat therapy (see Denny in "Citations" list below). Patients with infantile and juvenile gangliosidoses commonly suffer from seizure disorders, and use of the ketogenic diet in these patients may therefore also improve seizure management.
Primary Outcome
The survival duration of patients with infantile and juvenile forms of gangliosidoses will be assessed, in order to judge the clinical impact of the Syner-G therapy regimen. This will be accomplished by recording the subject's age on the date of enrollment in this study, and the subject's age at the conclusion of this study, or on the date of their death, whichever comes first. The duration of each subject's survival, expressed in months and years, will be compared to available natural history d
Interventions
- OTHER Ketogenic Diet
- DRUG miglustat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-12-22 |
| Est. Completion | 2019-07-31 |
| Phase | Phase 4 |
Why NCT02030015 stopped before completion
NCT02030015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketogenic Diet is the first listed.
NCT02030015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02030015 about?
NCT02030015 is a clinical study titled "Synergistic Enteral Regimen for Treatment of the Gangliosidoses". The investigators hypothesize that a combination therapy using miglustat and the ketogenic diet for infantile and juvenile patients with gangliosidoses will create a synergy that 1) improves overall survival for patients with infantile or juvenile gangliosidoses, and 2) improves neurodevelopmental c...
What is the current status of trial NCT02030015?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2015-12-22. Estimated completion is 2019-07-31.
What interventions are being tested in trial NCT02030015?
The interventions under investigation include: Ketogenic Diet (OTHER), miglustat (DRUG).
Who is sponsoring clinical trial NCT02030015?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02030015's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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