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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 is a Phase 4 study that was terminated before completion, run by University of Minnesota. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02030015
The ClinicalTrials.gov registry entry for NCT02030015 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketogenic Diet is the first listed.
NCT02030015 reports 0 study locations.
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.
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