NCT05605301CompletedPhase 2
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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 derived parameters. Statistical analysis will not be performed because of the small n, but this will nevertheless establish the PK profile of 2DG in people with epilepsy. The most important parameter will be the AUC which determines drug exposure.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 22 Oct 2022
- Start date
- 2 Sept 2022
- Primary completion date
- 5 Feb 2024
- Lead sponsor
- University of Virginia
- Diseases
- Epilepsy
- NCT number
- NCT05605301
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 9
- From 2 Sept 2022 to the primary completion date, 5 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Occurrence of non-epileptic psychogenic spells within 2 years prior to enrollment.
- Previous therapeutic use of 2DG.
- Use of an investigational medication within 2 months prior to enrollment.
- History of status epilepticus within 6 months prior to enrollment.
Other illness
- Clinically significant psychiatric or medical disease.
- Progressive structural brain lesion or illness likely to progress during the study.
Lab values
- Current or past history of diabetes or any abnormality of glucose metabolism.
- Use of glucocorticoids, hypoglycemic agents (e.g. metformin) or any drug that alters glucose levels.
- Use of any drug that is expected to alter glucose absorption, metabolism or serum measurements.
- Baseline prolongation of the QTc interval \> 450 msec.
- Elevated ALT or AST more than 1.5 times upper reference limit.
- Baseline fasting glucose \< 60 or \> 110.
Other
- Pregnant or nursing women.
- Supine systolic blood pressure \< 90 or \> 160 mm Hg or diastolic \> 90 mm Hg, or pulse \< 60 or \> 110 BPM.
- Clinically significant abnormal 12-lead ECG.
- Clinically significant abnormal result by speckle tracking echocardiography (STE).
Who the study is looking for
- Confirmed diagnosis of epilepsy. For the purpose of inclusion, the seizure types include complex partial, simple partial motor, primary generalized tonic-clonic, secondary generalized tonic-clonic, tonic, clonic and atonic seizures, as well as simple partial and absence seizures.
- Stable treatment regimen with no change in antiepileptic drugs or antiepileptic drug doses for 28 days prior to enrollment.
- Women of childbearing potential must be using a standard method of birth control and agree not to become pregnant during the trial. Men must agree to not father a child during the trial.
- BMI must be between 18 and 35.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia School of Medicine Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.