Trials / Not Yet Recruiting
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
| Type | Name | Description |
|---|---|---|
| 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. |
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
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07432490. Inclusion in this directory is not an endorsement.