Galactose Supplementation for the Treatment of MOGHE

Refractory Epilepsy Clinical Trial

— GATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833322
• Other study ID #: NEUROLOGIAHRI-01
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2021
• Source: Hospital Ruber Internacional
• Contact: Angel Aledo-Serrano, MD PhD
• Phone: 0034-913875250
• Email: aaledo[@]neurologiaclinica.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: October 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Disorders of Glycosylation
• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy
• SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation

Intervention

Dietary Supplement:
• D-Galactose
Galactose supplementation, once per day, up to 1.5g/kg per day

Locations

Country	Name	City	State
Spain	Hospital Ruber Internacional	Madrid	Madrid, Comunidad De

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Ruber Internacional

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency	Seizure diary	6 months
Primary	Epileptiform activity at EEG	Epileptiform activity quantification (per epoch)	6 months
Secondary	Behavioral assessment	Teacher and Parent Rating Scale (SNAP-IV) and Conners Continuous Performance Test (CPT-II)	6 months
Secondary	Cognitive assessment	Evaluated with Wechsler Intelligence Scale for Children (WISC-IV) and Behavior Rating Inventory of Executive Function-2 (BRIEF-2)	6 months