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NCT05605301 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
A Phase 2 study of Epilepsy; Seizure, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT05605301 is a Phase 2 study of Epilepsy; Seizure that has completed, run by University of Virginia. The registered enrollment target is 9 participants, below the 784-participant average among 4 other Epilepsy; Seizure trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05605301, a Phase 2 study of Epilepsy; Seizure, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This project studies how 2-deoxy-glucose (2DG) pills are absorbed and distributed in people with epilepsy. 2DG is similar to glucose, the main energy source for the brain, but it cannot be used as energy. During seizures, neurons are at a very high metabolic state with huge glucose metabolism as glycolysis is accelerated to supply the high metabolic needs of a seizure. 2DG is taken up by cells but cannot be metabolized by the first enzyme in the glycolytic pathway, thus is stops, or "clogs up", glycolysis. Since brain metabolism is almost entirely dependent on glucose as an energy source, glycolysis is arrested and may stop seizures. It is hoped that 2DG will stop seizures by interfering with the brain's energy use. This is an open-label phase 2 study of the pharmacokinetics (PK), safety, and tolerability of 2DG administered orally to adult epilepsy patients. A 3-level 2DG dose escalation is planned in sequential cohorts of 3 subjects in each cohort with review of each cohort before proceeding to the next cohort. On the day of oral 2DG exposure, subjects will receive a single dose of 40 mg in the first cohort, a single dose of 60 mg in the second cohort, and two 60 mg doses (60 mg bid) in the third cohort. After 3 subjects have completed dosing at Dose Level 1 (40 mg/day), the safety and PK results will be reviewed. The Study Committee will determine if the next cohort should be enrolled at Dose Level 2 (60 mg/day). The same procedure will be repeated to determine if the next cohort should be enrolled at Dose Level 3 (60 mg bid = 120 mg/day). If the Study Committee determines that the most recent dose is not tolerated or that there are significant adverse events, the subsequent Dose Level will not be enrolled. A standard time-concentration curve will be constructed from the 2DG levels obtained from the PK blood draws. Parameters will be calculated for: time to maximum concentration (tmax), maximum concentration (Cmax), elimination rate, half-life (t1/2), AUC, and
Conditions Studied
Interventions
- DRUG Oral 2-Deoxy-D-Glucose (2DG)
Study Locations (1)
Virginia
- University of Virginia School of Medicine - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2024-02-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05605301
The ClinicalTrials.gov registry entry for NCT05605301 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 784-participant average among 4 other Epilepsy; Seizure trials with a reported enrollment target (99% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Epilepsy; Seizure appearing as the primary indexed condition, and to 1 intervention - of which Oral 2-Deoxy-D-Glucose (2DG) is the first listed.
NCT05605301 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT05605301 about?
NCT05605301 is a clinical study titled "Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy". This project studies how 2-deoxy-glucose (2DG) pills are absorbed and distributed in people with epilepsy. 2DG is similar to glucose, the main energy source for the brain, but it cannot be used as energy. During seizures, neurons are at a very high metabolic state with huge glucose metabolism as gly...
What is the current status of trial NCT05605301?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2022-09-02. Estimated completion is 2024-02-05.
What conditions does trial NCT05605301 study?
This clinical trial studies the following conditions: Epilepsy; Seizure.
What interventions are being tested in trial NCT05605301?
The interventions under investigation include: Oral 2-Deoxy-D-Glucose (2DG) (DRUG).
Who is sponsoring clinical trial NCT05605301?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05605301 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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