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

NCT07432490 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

  • Glut1 Deficiency
  • GLUT1DS1

Interventions

DRUG

L-fucose

L-fucose will be administered as 500 mg/kg to a maximum of 10 g three times per day by mouth.

OTHER

Placebo

Placebo will be composed of micro-cellulose powder with a small amount of Stevia for taste mimicking, to be taken at 500 mg/kg for a maximum of 10 g three times per day by mouth.

Sponsors & Collaborators

  • Glut1 Deficiency Foundation

    collaborator UNKNOWN

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Rodrigo T. Starosta, MD, PhD · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-05
Primary Completion
2027-07-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07432490 on ClinicalTrials.gov