NCT07432490 A Phase II Study With Exploratory Outcomes of Fucose Supplementation in GLUT1 Deficiency Syndrome
| NCT ID | NCT07432490 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Oregon Health and Science University |
| Condition | Glut1 Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 16 participants in total. It began in 2026-05-05 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 6. Enrollment in an investigational new drug trial for G1DS within one year of enrollment
Contact & Investigator
Rodrigo T. Starosta, MD, PhD
STUDY DIRECTOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT07432490 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glut1 Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07432490 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07432490 currently recruiting?
Yes, NCT07432490 is actively recruiting participants. Contact the research team at byerlee@ohsu.edu for enrollment information.
Where is the NCT07432490 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT07432490 clinical trial?
NCT07432490 is sponsored by Oregon Health and Science University. The principal investigator is Rodrigo T. Starosta, MD, PhD at Oregon Health and Science University. The trial plans to enroll 16 participants.