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A Phase II Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Phase II Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome

A Phase II Randomized, Double-blind, Placebo-controlled, Cross-over Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome

NCT07432490•Oregon Health and Science University

View on ClinicalTrials.gov

Summary

This is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of L-fucose supplementation in subjects with GLUT1 deficiency syndrome (GLUT1DS).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years
•2. Confirmed diagnosis of GLUT1DS, including at least 2 out of the following 3: molecular genetic testing showing a pathogenic or likely pathogenic variant in SLC2A1; documented hypoglycorrhachia with a CSF:blood glucose ratio ≤ 0.6; clinical features consistent with GLUT1DS (epilepsy, movement disorders, ataxia, intellectual disability, dysarthria)
•3. Presence of ataxia

Exclusion Criteria

•1. Inability to swallow liquids
•2. Change in neurological medications (either medication itself or medication dosages) in the past 90 days
•3. Use of fucose- or mannose-containing supplements within one year of enrollment
•4. Presence of hepatic, renal, hematological, or concomitant metabolic disorders, as assessed by the presence of a previous diagnosis of such disorders (for instance, chronic kidney disease, liver cirrhosis, diabetes mellitus) or by the following laboratory values, which will be considered if obtained clinically up to 90 days before enrollment (if this is not available, laboratory tests will be obtained prior to first study visit):
•1. Any degree of hepatic impairment based on the Child-Pugh classification
•2. eGFR (as measured by serum creatinine or cystatin C) \< 60 mg/min/1.73m2
•3. Hemoglobin A1c \> 6.5%
•4. Hemoglobin level below the lower limit of normal (LLN) for sex and age
•5. Platelet counts below the LLN for sex and age
•5. Subjects who are pregnant, breastfeeding, or planning to become pregnant within one year of enrollment
+1 more criteria

Locations (1)

Oregon Health and Science University

Portland, Oregon, United States

Key Dates

Start Date

May 1, 2026

Primary Completion Date

May 1, 2027

Completion Date

August 1, 2027

Last Updated

February 25, 2026

Enrollment

ESTIMATED participants

Conditions

Glut1 DeficiencyGLUT1DS1

Interventions

L-fucose

DRUG

Placebo

OTHER

Contacts

Celena Byerlee-Dixon

CONTACT

503-494-7004 byerlee@ohsu.edu

The Glucose Transporter Type I Deficiency (G1D) Registry

NCT02013583

GLUT1 Deficiency SyndromeGlucose Transporter Type 1 Deficiency Syndrome+2 more

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COMPLETEDPHASE1

Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)

NCT02018315

Glucose Transporter Type 1 Deficiency SyndromeGLUT1 Deficiency Syndrome

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome

Inclusion Criteria

Exclusion Criteria

The Glucose Transporter Type I Deficiency (G1D) Registry

Treatment Development for Glucose Transporter Type I Deficiency Syndrome (G1D)

Triheptanoin (C7 Oil), a Food Supplement, for Glucose Transporter Type I Deficiency (G1D)