Galactose Supplementation for the Treatment of MOGHE

NCT ID: NCT04833322

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before-and-after pilot clinical trial with a single group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm group

Galactose supplementation

Group Type EXPERIMENTAL

D-Galactose

Intervention Type DIETARY_SUPPLEMENT

Galactose supplementation, once per day, up to 1.5g/kg per day

Interventions

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D-Galactose

Galactose supplementation, once per day, up to 1.5g/kg per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Ruber Internacional

OTHER

Sponsor Role lead

Responsible Party

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Angel Aledo-Serrano

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Angel Aledo-Serrano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Ruber Internacional

Locations

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Hospital Ruber Internacional

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Angel Aledo-Serrano, MD PhD

Role: CONTACT

0034-913875250

Ana Rodriguez

Role: CONTACT

0034-913875250

Facility Contacts

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Angel A Aledo-Serrano, MD PhD

Role: primary

0034-913875250

Other Identifiers

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NEUROLOGIAHRI-01

Identifier Type: -

Identifier Source: org_study_id

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