Galactose Supplementation for the Treatment of MOGHE (GATE)

Fresenius

Status: Unknown

Conditions: SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation; Refractory Epilepsy

Treatments: Dietary Supplement: D-Galactose

Study type: Interventional

Funder types: Other

Identifiers

NCT04833322

NEUROLOGIAHRI-01

Details and patient eligibility

About

Mild malformation of cortical development with oligodendroglial hyperplasia in epilepsy (MOGHE) is a new entity frequently associated with refractory epilepsy and neurodevelopmental disorders. Recently, it has been associated to SLC35A2 (Solute Carrier Family 35 Member A2) brain mosaic pathogenic variants. In addition, patients with germline SLC35A2 pathogenic variants improve with galactose supplementation. Therefore, the investigators aim to elucidate whether d-galactose as an add-on treatment might improve epilepsy and developmental outcomes in patients with MOGHE.

Enrollment: 8 estimated patients

Sex: All

Ages: 2 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue.
• Epilepsy refractoriness or ongoing epileptiform activity at EEG.

Exclusion criteria

• Allergy to galactose or supplement components.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Single arm group

Experimental group

Description:

Galactose supplementation

Treatment:

Dietary Supplement: D-Galactose