actate infusion in GLUT1DS

Phase 1

• Conditions: In glucose transporter 1 deficiency syndrome (GLUT1DS) cerebral glucose uptake from the systemic blood circulation is limited, because of deficient transport of glucose across the blood-brain barrier by the transporter protein (GLUT1). Classically patients present with developmental problems, movement disorders and severe epilepsy. There is no curative treatment for GLUT1DS, and anti-epileptic drugs usually have little to no effect.; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-003676-39-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-09
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 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 but without beneficial effects.
- Age > 6 years.
- Informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified