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Anti-metabolites

Sequential ascending dose cohort for Epilepsy

Phase 2
Waitlist Available
Led By Nathan B Fountain, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of drug administration until 24 hours post-dose
Awards & highlights

Study Summary

This trial studies how 2DG pills are absorbed and distributed in patients with epilepsy to see if they can stop seizures.

Eligible Conditions
  • Epilepsy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of drug administration until 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of drug administration until 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events
Pharmacokinetics

Side effects data

From 2011 Phase 2 trial • 55 Patients • NCT00062374
65%
Fatigue
64%
Hypocalcemia
60%
Nausea
58%
White blood cell count decrease
56%
Neutrophil count decrease
55%
Hemoglobin decrease
45%
Diarrhea
38%
Platelet count decreased
36%
Hyponatremia
31%
Hypophosphatemia
29%
Anorexia
29%
Hypokalemia
27%
Abdominal pain/cramping
22%
Hypomagnesemia
22%
Vomiting
20%
Hyperglycemia
20%
Hyperkalemia
20%
Lymphocyte count decrease
20%
Neuropathy-sensory
20%
Hypoalbuminemia
18%
Alanine aminotransferase increase
13%
Dyspnea
13%
Aspartate aminotransferase increase
11%
Creatinine
11%
Dehydration
11%
Dizziness
11%
Edema
9%
Thrombosis
9%
Alopecia
9%
Hypernatremia
9%
Weight loss
7%
Hearing impaired
7%
Constipation
7%
Dyspepsia
7%
Mood alteration/anxiety
7%
Taste disturbance
5%
Febrile neutropenia
5%
Dysphagia
5%
Pain, other
5%
Hypoglycemia
5%
Pharyngeal mucositis
4%
Hemorrhage, NOS
4%
CNS/cerebrovascular ischemia
4%
Chest pain
2%
Gastrointestinal disorder
2%
Cardiovascular, other
2%
Seizure
2%
Hypotension
2%
Muscle weakness
2%
Creatinine increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sequential ascending dose cohortExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oral 2-Deoxy-D-Glucose (2DG)
2022
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Epilepsy FoundationOTHER
10 Previous Clinical Trials
406 Total Patients Enrolled
8 Trials studying Epilepsy
363 Patients Enrolled for Epilepsy
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,245,022 Total Patients Enrolled
1 Trials studying Epilepsy
294 Patients Enrolled for Epilepsy
University of Wisconsin, MadisonOTHER
1,182 Previous Clinical Trials
3,167,378 Total Patients Enrolled
5 Trials studying Epilepsy
161 Patients Enrolled for Epilepsy

Media Library

2-Deoxy-D-Glucose (2DG) (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05605301 — Phase 2
Epilepsy Research Study Groups: Sequential ascending dose cohort
Epilepsy Clinical Trial 2023: 2-Deoxy-D-Glucose (2DG) Highlights & Side Effects. Trial Name: NCT05605301 — Phase 2
2-Deoxy-D-Glucose (2DG) (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05605301 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being treated in this clinical trial?

"Affirmative. Clinicaltrials.gov's records confirm that this clinical trial is actively recruiting participants, having been first posted on September 2nd 2022 and last edited on October 28th of the same year. The study requires 9 individuals from a single site to take part in it."

Answered by AI

Is there enrollment availability for this research project?

"According to the clinicaltrials.gov database, this research project is still recruiting participants as of October 28th 2022. The study was originally posted on September 2nd 2020."

Answered by AI

Has the Sequential ascending dose cohort received regulatory authorization?

"Our team at Power has given the safety of Sequential ascending dose cohort a score of 2, as it is currently in Phase 2 with evidence demonstrating security but no proof yet that it is effective."

Answered by AI

Are those aged 75 or younger permissible to partake in this research endeavor?

"This research project has set the age range of 18 and 60 years old as its inclusion criteria. Simultaneously, there are 122 studies targeting participants below 18 or over 65 respectively."

Answered by AI

Could I potentially join this clinical investigation?

"To qualify for this epilepsy trial, candidates must be between 18 and 60 years of age. In addition to confirming their diagnosis of the neurological disorder, participants should have a consistent antiepileptic treatment plan that has not changed in the last 28 days. Women capable of childbearing are also required to use contraception throughout the study and men need to abstain from fathering offspring during its duration. Finally, for enrolment consideration all individuals ought to fall within an acceptable BMI range (18-35)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy
Nathan Fountain, MD 2022. "Pharmacokinetics Study of Oral 2-Deoxy-D-Glucose (2DG) in Subjects With a Confirmed Diagnosis of Epilepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05605301.
~3 spots leftby Apr 2025
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