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Triheptanoin for Glut1 Deficiency Syndrome
Study Summary
This trial will study the effects of C7 supplementation on 45 subjects with G1D who are not receiving any dietary therapy. EEG activity, IQ, language, working memory, processing speed, emotional and behavioral functioning, ataxia, and other neuropsychological and neurological performance indices will be evaluated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 20 Patients • NCT02036853Trial Design
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- I have been diagnosed with G1D confirmed by genetic testing or a PET scan.I have a chronic stomach or bowel condition like IBS, Crohn's, or colitis.I am not pregnant, breastfeeding, or planning to become pregnant and agree to use birth control during the study.I haven't started a new seizure medication in the last 3 months.My BMI is 30 or higher.I am willing and able to give my consent, or my guardian can consent for me.I am between 2 and 35 years old.You are allergic or sensitive to C7.I have a separate metabolic or genetic condition.
- Group 1: Triheptanoin
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What potential risks accompany the use of Triheptanoin?
"Due to the lack of data demonstrating Triheptanoin's efficacy, our team at Power gave it a rating of 2 on its safety scale. This is because Phase 2 trials have yet to prove its effectiveness in clinical settings."
Who meets the criteria for enrollment in this experiment?
"This experiment is seeking 45 volunteers aged 24 Months to 35 who are experiencing aura. Furthermore, applicants must either be following a modified Atkins diet or have not been using any dietary therapy for the past month. Both male and female participants can apply."
Has previous research been conducted utilizing Triheptanoin?
"Presently, three clinical trials for Triheptanoin are underway with none in the third phase. Dallas and another city are conducting experiments on this drug."
How many participants are being recruited for this clinical experiment?
"This project has concluded its recruitment of participants. Initially posted on April 18th 2018, the study was last edited on August 26th 2022. However, there are currently 1729 clinical trials seeking enrolment from those with aura and 3 more looking for Triheptanoin patients."
Is enrollment into this research endeavor open at the moment?
"According to clinicaltrials.gov, this research project has not been actively seeking participants since August 26th 2022. Though the trial is no longer recruiting subjects, there are 1,732 other studies currently enrolling volunteers."
Does the eligibility criteria for this trial encompass individuals aged 20 and over?
"This study is inviting patients aged 2 and above, up to 35 years old."
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