Sodium Lactate Infusion in GLUT1DS Patients

NCT04112862 | Completed Early Phase 1 DMC

• 1 other identifier: 109147
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effect of lactate infusion on epileptic discharges on EEG and seizure frequency in glucose transporter 1 deficiency syndrome (GLUT1DS) patients.

Conditions

GLUT1 Deficiency Syndrome; GLUT1DS1; GLUT1DS2; Epilepsy; Lactic Acid Blood Increased; Ketogenic Dieting

Keywords

GLUT1 deficiency syndrome; sodium lactate infusion; epilepsy

Outcome Measures

Primary Outcomes (1)

• Number of changes in epileptic discharges on EEG during the infusion of lactate.

  All subjects have frequent epileptic discharges on EEG. We want to objectify the change in epileptic discharges on EEG during and after the infusion of sodium lactate.

  1 day

Secondary Outcomes (8)

• Change in seizure frequency clinical visible by caregivers during and after infusion of sodium lactate.

  1 day

• Concentration of lactate in blood during and after sodium lactate infusion

  1 day

• Concentration of glucose in blood during and after sodium lactate infusion

  1 day

• Concentration of sodium in blood during and after sodium lactate infusion

  1 day

• Concentration of potassium in blood during and after sodium lactate infusion

  1 day

Study Arms (1)

Intervention

EXPERIMENTAL

three GLUT1DS patients with drug resistant epilepsy who tried the ketogenic diet without any benefits.

Other: sodiumlactate

Interventions

sodiumlactate OTHER

intravenous sodiumlactate 600mmol/L

Intervention

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with GLUT1DS and known in our center.
• Baseline characteristics include a high frequency of clinical seizures and epileptic discharges on EEG.
• History of trying ketogenic diet with good compliance without beneficial effects.
• Age \> 6 years.
• Informed consent.

You may not qualify if:

• Additional medical condition or illness that impairs the patient's ability to participate in the study (for example actual treatment of a malignancy, active infection, poorly controlled diabetes mellitus, hypertension, organ failure, clinically significant haematological or biochemical abnormalities).
• Elevated serum sodium (\> 145 mmol/L).
• Participation in another interventional study at start of the study or during the study.
• Presence of known panic disorders or a history of panic attacks.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500GA, Netherlands

Location

MeSH Terms

Conditions

Glut1 Deficiency Syndrome; Dystonia 18; Epilepsy; Hyperlactatemia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, interventional, explorative, open label, proof of principle study

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: October 2, 2019
• Study Start: May 20, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)