Refractory EpilepsyGATENCT04833322
Galactose Supplementation for the Treatment of MOGHE
A study testing D-Galactose in people with Refractory Epilepsy and SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation, run by Hospital Ruber Internacional at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Refractory Epilepsy, SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
- What is being tested?
- D-Galactose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue.
- Epilepsy refractoriness or ongoing epileptiform activity at EEG.
Who cannot join
- Allergy to galactose or supplement components.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Ruber Internacional
Madrid, Madrid, Comunidad de, 28034
Angel A Aledo-Serrano, MD PhD, 0034-913875250, aaledo@neurologiaclinica.es
Angel Aledo-Serrano, MD PhD
About this study
Official title: 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.
- Conditions
- Refractory Epilepsy, SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
- Being tested
- D-Galactose
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-GalactoseDietary supplement
Galactose supplementation, once per day, up to 1.5g/kg per day
| Study group | Role | What they receive |
|---|---|---|
| Single arm group | Experimental | Galactose supplementation Receives: Dietary Supplement: D-Galactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency
Seizure diary
Measured: 6 months
Epileptiform activity at EEG
Epileptiform activity quantification (per epoch)
Measured: 6 months
Secondary outcomes (2)
Behavioral assessment
Teacher and Parent Rating Scale (SNAP-IV) and Conners Continuous Performance Test (CPT-II)
Measured: 6 months
Cognitive assessment
Evaluated with Wechsler Intelligence Scale for Children (WISC-IV) and Behavior Rating Inventory of Executive Function-2 (BRIEF-2)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start15 Jan 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before-and-after pilot clinical trial with a single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Ruber Internacional
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angel Aledo-Serrano, Hospital Ruber Internacional
- Investigators
- Angel Aledo-Serrano, MD, PhD, Principal investigator, Hospital Ruber Internacional
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833322
- Sponsor's protocol ID
- NEUROLOGIAHRI-01
- Acronym
- GATE
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galactose Supplementation for the Treatment of Patients With Mild Malformation of Cortical Development With Oligodendroglial Hyperplasia in Epilepsy (MOGHE): a Pilot Trial
- ClinicalTrials.gov ID
- NCT04833322
- Acronym / sponsor ID
- GATE / NEUROLOGIAHRI-01
- Conditions
- Refractory Epilepsy, SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hospital Ruber InternacionalUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-and-after pilot clinical trial with a single group
| Arm | Type | Receives |
|---|---|---|
| Single arm group | Experimental | Dietary Supplement: D-GalactoseGalactose supplementation |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- MOGHE diagnosis at histopathological examination of the epilepsy surgery tissue.
- Epilepsy refractoriness or ongoing epileptiform activity at EEG.
Key exclusion criteria (1 listed)
- Allergy to galactose or supplement components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D-GalactoseGalactose supplementation, once per day, up to 1.5g/kg per day | Dietary supplement | Single arm group |
Primary outcome
Seizure frequency
Time frame: 6 months
Seizure diary
Epileptiform activity at EEG
Time frame: 6 months
Epileptiform activity quantification (per epoch)
2 secondary outcomes
Behavioral assessment
Time frame: 6 months
Cognitive assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Refractory Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
Recruiting
Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Recruiting
Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy
Refractory Epilepsy
RecruitingPhase 1
Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy
Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Aledo-Serrano, MD, PhD principal investigator
Hospital Ruber Internacional
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D-Galactose in people with Refractory Epilepsy and SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation, run by Hospital Ruber Internacional at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angel Aledo-Serrano, MD PhD (0034-913875250, aaledo@neurologiaclinica.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.