AVTX-801 D-galactose Supplementation in SLC35A2-CDG

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Eva Morava-Kozicz
Study ID
NCT05402384
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Eligibility Criteria

Sex
ALL
Age
1 Month - N/A
Healthy Volunteers
Not accepted

Interventions

  • AVTX-801 — DRUG
    Medical grade D-galactose dosage:2.0 g/kg/day
  • Placebo — DRUG
    Matching placebo

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of AVTX-801 in subjects with SLC35A2-CDG

Key Dates

Start date
Jan 31, 2027
Status verified
Jun 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: AVTX-801, then Placebo
    Each treatment period is 24 weeks, with 6-week washout period in between.
  • Placebo Comparator: Placebo, then AVTX-801
    Each treatment period is 24 weeks, with 6-week washout period in between.

Primary Outcome Measure

Number of major motor seizure frequency [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic MinnesotaRochesterMinnesota55905-

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By research site
Mayo Clinic Minnesota· Rochester, MN