Galactose Supplementation for the Treatment of MOGHE (GATE)

April 3, 2021 updated by: Angel Aledo-Serrano, Hospital Ruber Internacional

Galactose Supplementation for the Treatment of Patients With Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE): a Pilot Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Ruber Internacional
        • Contact:
        • Principal Investigator:
          • Angel Aledo-Serrano, MD PhD
        • Sub-Investigator:
          • Antonio Gil-Nagel, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm group
Galactose supplementation
Dietary supplement: D-Galactose
Galactose supplementation, once per day, up to 1.5g/kg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure frequency
Time Frame: 6 months
Seizure diary
6 months
Epileptiform activity at EEG
Time Frame: 6 months
Epileptiform activity quantification (per epoch)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral assessment
Time Frame: 6 months
Teacher and Parent Rating Scale (SNAP-IV) and Conners Continuous Performance Test (CPT-II)
6 months
Cognitive assessment
Time Frame: 6 months
Evaluated with Wechsler Intelligence Scale for Children (WISC-IV) and Behavior Rating Inventory of Executive Function-2 (BRIEF-2)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Ruber Internacional

Investigators

  • Principal Investigator: Angel Aledo-Serrano, MD, PhD, Hospital Ruber Internacional

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

April 3, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

April 6, 2021

Last Update Submitted That Met QC Criteria

April 3, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEUROLOGIAHRI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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