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Clinical Trial Summary

This is a single-site, open-label, phase II trial of C7, a food supplement or medical food, for the development of treatment outcome measures for glucose transporter type I deficiency (G1D). The primary outcome measures are: 1. Safety and tolerability of C7 as measured by changes in comprehensive blood work, including lipid and free fatty acid panels, self-reported side effects and clinical exam; 2. Changes in brain metabolic rate by MRI and EEG measurements during C7 treatment; and 3. Maintenance of ketosis in G1D patients on ketogenic diet, as measured by serial ketone levels during treatment initiation.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02021526
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date December 2015
Completion date June 2020

See also
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Completed NCT04399954 - Evaluation of Ketoflo N/A
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Completed NCT02915211 - Evaluation of Keyo in Children With Epilepsy N/A
Active, not recruiting NCT02000960 - Pilot Study of Triheptanoin in Patients With Glucose Transporter 1 Deficiency Syndrome Phase 2
Active, not recruiting NCT03181399 - Diet Treatment Glucose Transporter Type 1 Deficiency (G1D) Phase 2
No longer available NCT02018302 - Post Study Continuation of C7 for G1D