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NCT03041363 · ClinicalTrials.gov registry record · Phase 1
Treatment Development of Triheptanoin (G1D)
A Phase 1 study of Epilepsy and Glucose Metabolism Disorders, sponsored by Juan Pascual.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03041363: Completed Phase 1 study of Epilepsy and Glucose Metabolism Disorders, sponsored by Juan Pascual.
NCT03041363 is a Phase 1 study of Epilepsy and Glucose Metabolism Disorders that has completed, run by Juan Pascual. The registered enrollment target is 12 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03041363, a Phase 1 study of Epilepsy and Glucose Metabolism Disorders, has completed, sponsored by Juan Pascual.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed with glucose transporter type 1 deficiency disorder (G1D).
Primary Outcome
To determine the MTD as a percentage of calories consumed in pediatric and adult patient population.
Conditions Studied
Interventions
- DRUG Triheptanoin
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2017-03-29 |
| Est. Completion | 2017-12-22 |
| Phase | Phase 1 |
What the finished NCT03041363 record still lists
NCT03041363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (99% lower).
The record links to 7 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which Triheptanoin is the first listed.
NCT03041363 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03041363 about?
NCT03041363 is a clinical study titled "Treatment Development of Triheptanoin (G1D)". To determine the maximum tolerated dose (MTD), as a percentage of calories consumed, of triheptanoin (C7 oil; C7) in a pediatric and adult patient population genetically diagnosed with glucose transporter type 1 deficiency disorder (G1D).
What is the current status of trial NCT03041363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2017-03-29. Estimated completion is 2017-12-22.
What conditions does trial NCT03041363 study?
This clinical trial studies the following conditions: Epilepsy, Glucose Metabolism Disorders, Glut1 Deficiency Syndrome 1, Autosomal Recessive, Glucose Transporter Type 1 Deficiency Syndrome, Glucose Transporter Protein Type 1 Deficiency Syndrome.
What interventions are being tested in trial NCT03041363?
The interventions under investigation include: Triheptanoin (DRUG).
Who is sponsoring clinical trial NCT03041363?
This trial is sponsored by Juan Pascual, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03041363 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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12 144th of 160 higher than 16 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
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