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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from time of drug administration until 24 hours post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of drug administration until 24 hours post-dose
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 • NCT0006237465%
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
759 Previous Clinical Trials
1,245,577 Total Patients Enrolled
1 Trials studying Epilepsy
294 Patients Enrolled for Epilepsy
University of Wisconsin, MadisonOTHER
1,193 Previous Clinical Trials
3,161,830 Total Patients Enrolled
5 Trials studying Epilepsy
161 Patients Enrolled for Epilepsy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have used 2DG as a treatment before.You have a brain condition that is getting worse or is expected to get worse during the study.You have experienced episodes that look like seizures but are not caused by epilepsy in the past two years.You are taking medications that affect your blood sugar levels, like steroids or certain diabetes medications.You have a serious mental or physical illness that could affect your ability to participate in the study.You have taken an experimental medication within the past 2 months.You have experienced a severe seizure that lasted a long time within the past 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Sequential ascending dose cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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