What side effects are associated with this type of intervention?

Common treatments for epilepsy, particularly those enhancing GABA-A receptor activity like Diazepam, often have side effects such as somnolence, decreased appetite, irritability, restlessness, and potential dependence. Other benzodiazepines share similar side effects, including psychomotor impairment, amnesia, and withdrawal symptoms. Valproate can cause nausea, somnolence, tremor, dizziness, weight gain, and hair loss, while topiramate may lead to paresthesia, fatigue, anorexia, weight loss, memory difficulties, and concentration issues.

What prior FDA approvals exist?

Several FDA-approved drugs for the treatment of epilepsy work by enhancing GABAergic activity, similar to diazepam. Benzodiazepines such as clonazepam and lorazepam are commonly used for their ability to enhance GABA-A receptor activity, leading to increased neuronal inhibition and reduced seizure activity. Additionally, barbiturates like phenobarbital also enhance GABAergic activity and are approved for epilepsy treatment. These medications help manage seizures by promoting inhibitory neurotransmission in the brain.

What other types of research exist?

Promising novel alternatives to Diazepam for epilepsy patients include ganaxolone, a synthetic neuroactive steroid approved for treating seizures in patients with CDKL5 deficiency disorder. Other emerging therapies and ongoing research into new antiseizure medications may also provide additional options.

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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

No Placebo-Only Group

Summary

This trial aims to see if diazepam can reduce seizures in patients with epilepsy linked to high levels of GAD65 antibodies. Diazepam helps calm brain activity by boosting the effect of a natural calming chemical, GABA. This approach is being tested because these patients often don't respond to usual treatments. Diazepam has been used as an anticonvulsant, but its usage has recently decreased.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in seizure frequency

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for epilepsy often target the modulation of neuronal activity to prevent seizures. Diazepam, a benzodiazepine, enhances the activity of GABA-A receptors, increasing neuronal inhibition and reducing seizure activity. This is crucial for epilepsy patients as it helps stabilize neuronal firing and prevent the excessive electrical activity that characterizes seizures. Other common AEDs include sodium channel blockers like carbamazepine and phenytoin, which reduce neuronal excitability by stabilizing inactive sodium channels, and calcium channel blockers like ethosuximide, which inhibit T-type calcium channels to prevent abnormal electrical activity. These mechanisms are vital for managing epilepsy, as they help maintain a balance between excitatory and inhibitory signals in the brain, reducing the frequency and severity of seizures.