NCT04833322

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

March 31, 2021

Last Update Submit

April 3, 2021

Conditions

Refractory EpilepsySLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Outcome Measures

Primary Outcomes (2)

  • Seizure frequency

    Seizure diary

    6 months

  • Epileptiform activity at EEG

    Epileptiform activity quantification (per epoch)

    6 months

Secondary Outcomes (2)

  • Behavioral assessment

    6 months

  • Cognitive assessment

    6 months

Study Arms (1)

Single arm group

EXPERIMENTAL

Galactose supplementation

Dietary Supplement: D-Galactose

Interventions

D-GalactoseDIETARY_SUPPLEMENT

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

Single arm group

Eligibility Criteria

Age2 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Allergy to galactose or supplement components.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Ruber Internacional

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Galactose

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Angel Aledo-Serrano, MD, PhD

    Hospital Ruber Internacional

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Aledo-Serrano, MD PhD

CONTACT

0034-913875250aaledo@neurologiaclinica.es

Ana Rodriguez

CONTACT

0034-913875250ensayosepi@neurologiaclinica.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Before-and-after pilot clinical trial with a single group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 6, 2021

Study Start

January 15, 2021

Primary Completion

September 1, 2021

Study Completion

October 1, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)