CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Triheptanoindrug
Likely dose
Triheptanoin 4 times per day (approximately every 6 hours), dosed evenlyAI-extracted
Key inclusion· 4
  • ✓Confirmed diagnosis of glucose transporter type 1 deficiency (G1D) by clinical genotyping at CLIA-certified laboratory or PET scan
  • ✓Age 24 months to 35 years old
  • ✓Stable diet on modified Atkins diet or no dietary therapy for at least 1 month
  • ✓Evidence of abnormal EEG with spike-wave discharges in the last 12 months
Key exclusion· 9
  • ✕Currently on dietary therapy (ketogenic diet, medium chain triglyceride supplemented diets, Atkins diet, low glycemic index diet)
  • ✕Chronic gastrointestinal disorder such as irritable bowel syndrome, Crohn's disease, or colitis
  • ✕BMI ≥30
  • ✕Independent, unrelated metabolic and/or genetic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181399
NCT03181399Phase 2Completed
CompareCT.gov

Dietary Treatment of Glucose Transporter Type 1 Deficiency (G1D)

University of Texas Southwestern Medical Center·interventional·Posted Jun 8, 2017·Updated Aug 7, 2025

In Brief

A Phase 2 clinical trial evaluating Triheptanoin for GLUT1DS1 and 6 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed Summary

Forty-five subjects receiving no dietary therapy with a proven G1D diagnosis will be enrolled. To evaluate the effect of C7 supplementation of a regular diet on a EEG activity in addition to IQ, language, working memory, processing speed, emotional and behavioral functioning, ataxia, and other neuropsychological and neurological performance indices in children and adults genetically diagnosed with G1D receiving a regular diet at enrollment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGLUT1DS1, Epilepsy, Glut1 Deficiency Syndrome 1, Autosomal Recessive, Glucose Metabolism Disorders, Glucose Transport Defect, Glucose Transporter Type 1 Deficiency Syndrome, Glucose Transporter Protein Type 1 Deficiency Syndrome
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 8, 2017
Enrollment StartApr 18, 2018
Primary CompletionSep 10, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 9.1 years ago

Interventions

Triheptanoindrug

. Triheptanoin will be taken 4 times per day (approximately every 6 hours: prior to breakfast, lunch and dinner and a mid-afternoon snack) by mouth. It is dosed 4 times per day, divided evenly.