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Benzodiazepine
Diazepam for Epilepsy
Phase 1 & 2
Waitlist Available
Led By Jeffrey Britton, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights
Study Summary
This trial will test whether diazepam reduces seizure frequency in people with a specific type of epilepsy.
Who is the study for?
This trial is for adults with drug-resistant focal epilepsy who have tried at least two anti-seizure medications without success. Participants must show high levels of GAD65 antibodies in their blood or CSF and not have changed their treatment in the last month. Pregnant or breastfeeding individuals, those with other seizure-related antibodies, alternative causes for epilepsy, current benzodiazepine use, or regular opiate use cannot join.Check my eligibility
What is being tested?
The study is testing if diazepam can reduce seizure frequency in patients whose epilepsy is associated with high levels of GAD65 antibodies. Diazepam's effectiveness as a treatment option will be evaluated by monitoring changes in seizure occurrences.See study design
What are the potential side effects?
Diazepam may cause drowsiness, fatigue, muscle weakness, and coordination problems. Some people might also experience confusion or slowed breathing especially when combined with other medications that affect brain function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in seizure frequency
Trial Design
1Treatment groups
Experimental Treatment
Group I: GAD65 Associated EpilepsyExperimental Treatment1 Intervention
Subjects diagnosed with GAD65 associated epilepsy, serum high-titer GAD65 positivity, trialed and failed at least 2 anti-seizure medications, at least 4 seizures per month will be started on diazepam.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diazepam
2016
Completed Phase 4
~2800
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,227 Previous Clinical Trials
3,771,638 Total Patients Enrolled
22 Trials studying Epilepsy
1,162 Patients Enrolled for Epilepsy
Jeffrey Britton, MDPrincipal InvestigatorMayo Clinic
Kelsey Smith, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have epilepsy that doesn't respond to medications and have tried two different medications without success.You have high levels of a specific antibody called GAD65 in your blood or cerebrospinal fluid.You have antibodies in your body that are linked to causing seizures.You have a different reason for having seizures other than epilepsy.You are currently taking a different medication called a benzodiazepine.You are currently taking opioid medication on a regular basis.
Research Study Groups:
This trial has the following groups:- Group 1: GAD65 Associated Epilepsy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled vacancies in this clinical trial?
"No, this particular trial is not looking for new patients at the moment. According to the website clinicaltrials.gov, which last updated information about this study on September 12th, 2022, 242 other trials are actively recruiting participants."
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