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Not Yet RecruitingNCT07432490

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

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
16 (estimated)
Sponsor
Oregon Health and Science University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2026-05-01
Primary completion
2027-05-01
Completion
2027-08-01
First posted
2026-02-25
Last updated
2026-02-25

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT07432490. Inclusion in this directory is not an endorsement.