Epilepsy; SeizurePhase 2NCT05605301

Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy

A Phase 2 study testing Oral 2-Deoxy-D-Glucose (2DG) in people with Epilepsy; Seizure, run by University of Virginia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Epilepsy; Seizure
What is being tested?: Oral 2-Deoxy-D-Glucose (2DG)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 2 Sep 2022to 5 Feb 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Occurrence of non-epileptic psychogenic spells within 2 years prior to enrollment.
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.
Clinically significant psychiatric or medical disease.
Previous therapeutic use of 2DG.

Show all 16Show fewer

Pregnant or nursing women.
Use of an investigational medication within 2 months prior to enrollment.
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.
Baseline prolongation of the QTc interval > 450 msec.
Clinically significant abnormal result by speckle tracking echocardiography (STE).
Elevated ALT or AST more than 1.5 times upper reference limit.
Baseline fasting glucose < 60 or > 110.
History of status epilepticus within 6 months prior to enrollment.
Progressive structural brain lesion or illness likely to progress during the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia School of Medicine
Charlottesville, Virginia, 22908

Other trials in United States

About this study

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.

Read the detailed description

The study will be conducted as a 1-day Monitored Dosing and Pharmacokinetics Period in an inpatient setting. Subjects will report to the hospital in a fasted state (since midnight) on the morning of the pharmacokinetics study. Subjects will continue to fast until one hour after the 2DG dose has been given. 2DG will be given as either a single oral dose (40 mg for Dose Level 1; 60 mg for dose level 2) or 60 mg bid (Dose Level 3). Blood for pharmacokinetic analysis will be drawn at time 0 (prior to drug administration), and then at 15, 30, 45, and 60 minutes and at 2, 4, 6, 12, and 24 hours after single dose 2DG administration. Blood for pharmacokinetic analysis will be drawn at time 0 (prior to drug administration) and then at 15, 30, 45, and 60 minutes and at 2, 4, 6, 12, and 24 hours after the last dose for Dose Level 3. Patients will be closely monitored for safety during and following dosing with 2DG.

Conditions: Epilepsy; Seizure
Being tested: Oral 2-Deoxy-D-Glucose (2DG)
Medical subject headings: Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral 2-Deoxy-D-Glucose (2DG)Drug
2DG will be formulated as an solid dosage form and administered orally.

Study groups in NCT05605301
Study group	Role	What they receive
Sequential ascending dose cohort	Experimental	Cohort 1 will receive single 40 mg dose once. Cohort 2 will receive single 60 mg dose once. Cohort 3 will receive (2) 60 mg dose on one occasion. Receives: Drug: Oral 2-Deoxy-D-Glucose (2DG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve From Time Zero to Last Observed Time Point (AUClast)
Area under the concentration-time curve from time zero to the last measurable concentration for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf)
Area under the concentration-time curve from time zero extrapolated to infinity for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose

Secondary outcomes (5)

Elimination Half-Life (t1/2)
Elimination half-life (t1/2) of 2-deoxy-D-glucose (2DG), estimated from the terminal phase of the concentration-time curve following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose
Elimination Rate Constant (Kel)
Elimination rate constant (Kel) of 2-deoxy-D-glucose (2DG), estimated from the terminal phase of the concentration-time curve following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose
Time of Last Observed Concentration (Tlast)
Time of the last observed measurable concentration of 2-deoxy-D-glucose (2DG) following dosing, calculated from blood samples collected at predefined time points. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose
Time to Maximum Observed Blood Concentration (Tmax)
Time to maximum observed blood concentration of 2-deoxy-D-glucose (2DG) following dosing, calculated from blood samples collected at predefined time points. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose
Maximum Observed Blood Concentration (Cmax)
Maximum observed blood concentration of 2-deoxy-D-glucose (2DG) following dosing, calculated from blood samples collected at predefined time points. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Measured: From time of drug administration until 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 20225 Feb 2024

First posted4 Nov 2022
Study start2 Sep 2022
Primary completion5 Feb 2024
Study completion5 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Epilepsy; SeizureStudies of the same condition, open and under way.
More trials run by University of VirginiaThe sponsor's other registered studies.
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 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Sequential
Model description: Subjects will be given 2DG orally during a single day of dosing at one of three sequential dose levels (a single dose of 40 mg for Dose Level 1, a single dose of 60 mg for Dose Level 2, or 60 mg bid for Dose Level 3). The total dose will not exceed 120 mg/day, or 60 mg maximum. as a single dose
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05605301
Sponsor's protocol ID: HSR210085
Status last verified: Jun 2026
First submitted: 22 Oct 2022
Last updated: 9 Jun 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingObservational study
Tumor Related Epilepsy
Epilepsy, Cancer
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingPhase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Primary Generalized Tonic-Clonic Seizures

All Epilepsy; Seizure trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
ClinicalTrials.gov ID: NCT05605301
Acronym / sponsor ID: HSR210085
Conditions: Epilepsy; Seizure
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Epilepsy Foundation, University of Wisconsin, Madison
Study start: 2 Sep 2022 (actual)
Primary completion: 5 Feb 2024 (actual)
Study completion: 5 Feb 2024 (actual)
First posted: 4 Nov 2022 (actual)
Results: Posted 9 Jun 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: Subjects will be given 2DG orally during a single day of dosing at one of three sequential dose levels (a single dose of 40 mg for Dose Level 1, a single dose of 60 mg for Dose Level 2, or 60 mg bid for Dose Level 3). The total dose will not exceed 120 mg/day, or 60 mg maximum. as a single dose

Arm	Type	Receives
Sequential ascending dose cohort	Experimental	Drug: Oral 2-Deoxy-D-Glucose (2DG)Cohort 1 will receive single 40 mg dose once. Cohort 2 will receive single 60 mg dose once. Cohort 3 will receive (2) 60 mg dose on one occasion.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 listed)

Occurrence of non-epileptic psychogenic spells within 2 years prior to enrollment.
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.
Clinically significant psychiatric or medical disease.

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
Oral 2-Deoxy-D-Glucose (2DG)2DG will be formulated as an solid dosage form and administered orally.	Drug	Sequential ascending dose cohort

Primary outcome

Area Under the Curve From Time Zero to Last Observed Time Point (AUClast)
Time frame: From time of drug administration until 24 hours post-dose
Area under the concentration-time curve from time zero to the last measurable concentration for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.
Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf)
Time frame: From time of drug administration until 24 hours post-dose
Area under the concentration-time curve from time zero extrapolated to infinity for 2-deoxy-D-glucose (2DG), calculated from blood samples collected at predefined time points following dosing. For the twice-daily cohort, the reported value reflects pharmacokinetic results following the second dose.

5 secondary outcomes

Elimination Half-Life (t1/2)
Time frame: From time of drug administration until 24 hours post-dose
Elimination Rate Constant (Kel)
Time frame: From time of drug administration until 24 hours post-dose
Time of Last Observed Concentration (Tlast)
Time frame: From time of drug administration until 24 hours post-dose
Time to Maximum Observed Blood Concentration (Tmax)
Time frame: From time of drug administration until 24 hours post-dose
Maximum Observed Blood Concentration (Cmax)
Time frame: From time of drug administration until 24 hours post-dose

Results and safety

Results posted to the registry on 9 Jun 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2DG 40 mg Single Dose	3	3
2DG 60 mg Single Dose	3	3
2DG 60 mg Twice Daily	3	3

Primary outcome: Area Under the Curve From Time Zero to Last Observed Time Point (AUClast)

Time frame: From time of drug administration until 24 hours post-dose. Mean (Standard Deviation). Unit: hour*ug/mL

Measure	2DG 40 mg Single Dose n = 3	2DG 60 mg Single Dose n = 3	2DG 60 mg Twice Daily n = 3
Value	2.81 (0.49)	2.93 (1.13)	4.16 (0.57)

Population analysed: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.

Primary outcome: Area Under the Curve From Time Zero Extrapolated to Infinity (AUCinf)

Time frame: From time of drug administration until 24 hours post-dose. Mean (Standard Deviation). Unit: hr*ug/mL

Measure	2DG 40 mg Single Dose n = 1	2DG 60 mg Single Dose n = 2	2DG 60 mg Twice Daily n = 2
Value	3.56 (NA)	3.19 (1.59)	4.71 (0.81)

Population analysed: All participants who received the assigned dose and had pharmacokinetic samples collected were included in the analysis.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of first dose through 14 days post-dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2DG 40 mg Single Dose	0 of 3 (0%)	3 of 3 (100%)	0 of 3
2DG 60 mg Single Dose	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
2DG 60 mg Twice Daily	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Limitations and caveats (from the sponsor): This was a small, open-label study with a limited sample size of nine participants and no control group. The study was not powered for statistical comparisons and results are descriptive in nature. Pharmacokinetic parameters were derived from a single day of dosing, which may limit generalizability to repeated dosing conditions. Pharmacokinetic measurements were often near the lower limit of detection, which may affect precision of parameter estimates.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Epilepsy; Seizure

RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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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.

Nathan B Fountain, MD principal investigator

University of Virginia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral 2-Deoxy-D-Glucose (2DG) in people with Epilepsy; Seizure, run by University of Virginia at 1 site in United States.

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 4 inclusion and 16 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: finished, as of the sponsor's last update on 9 Jun 2026. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve From Time Zero to Last Observed Time Point (AUClast) (time frame: From time of drug administration until 24 hours post-dose). 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?

On the ClinicalTrials.gov record for NCT05605301.

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 9 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.