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New treatment option for Absence Epilepsy
Official title Ketogenic Diet for New-Onset Absence Epilepsy
ClinicalTrials.gov ID: NCT04274179
What this study is testing
What is Absence epilepsy medications?
Absence epilepsy medications is an investigational medicine, being studied as a potential treatment for absence epilepsy.
Also referred to as Ethosuximide, valproate or lamotrigine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The ketogenic diet is a medical therapy for epilepsy that is used nearly predominantly for refractory epilepsy (after 2-3 drugs have been tried and failed). However, there is both published evidence for first-line use (infantile spasms, Glut1 deficiency syndrome) and also anecdotal experience (families choosing to change the child's (or the family' own) diet rather than use anticonvulsant medications).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12
You may be able to join if
- Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically.
- Normal intellect or mild disability
- EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation
- Daily reported absence seizures.
- Generalized convulsions allowed
You likely can't join if
- Previous treatment with any anticonvulsant drug
- Previous use of a ketogenic dietary therapy for epilepsy or any other condition
- Glut1 deficiency syndrome
- Metabolic disorder known that would preclude dietary therapy
- Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.
- Prior history of epilepsy (febrile seizures allowed)
See the full eligibility criteria
- Children ages 3-12 years at seizure onset with classic childhood absence epilepsy clinically.
- Normal intellect or mild disability
- EEG with confirmed 3/second spike-wave discharges, usually with hyperventilation
- Daily reported absence seizures.
- Generalized convulsions allowed
- Previous treatment with any anticonvulsant drug
- Previous use of a ketogenic dietary therapy for epilepsy or any other condition
- Glut1 deficiency syndrome
- Metabolic disorder known that would preclude dietary therapy
- Dietary restrictions for which a high fat, low carbohydrate diet would be precluded.
- Prior history of epilepsy (febrile seizures allowed)
- Unwilling to consent to study procedures or return for visits
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.