What side effects are associated with this type of intervention?

Common treatments for epilepsy, such as benzodiazepines (e.g., diazepam) and other antiepileptic drugs (AEDs) like valproate, have several known side effects. Benzodiazepines can cause drowsiness, dizziness, fatigue, and potential dependence with long-term use. Valproate may lead to nausea, somnolence, tremor, dizziness, weight gain, and hair loss, and is contraindicated in pregnancy due to teratogenic effects.

What prior FDA approvals exist?

Benzodiazepines, including diazepam, have been approved by the FDA for the treatment of epilepsy due to their ability to enhance the effect of the neurotransmitter GABA at the GABA-A receptor, thereby increasing inhibitory effects in the central nervous system and reducing seizure activity. Diazepam, in various forms such as oral, rectal gel, and more recently, nasal spray (VALTOCO), is commonly used for acute seizure management. Other benzodiazepines like lorazepam and clonazepam are also frequently used in epilepsy treatment for their similar mechanisms of action and efficacy in controlling seizures.

What other types of research exist?

Promising novel alternatives to VALTOCO for epilepsy patients include: 1) Cannabidiol (CBD) - a non-psychoactive compound from cannabis that has shown efficacy in reducing seizure frequency in certain types of epilepsy. 2) Cenobamate - a newer antiepileptic drug that has demonstrated significant seizure reduction in clinical trials. 3) Fenfluramine - originally an appetite suppressant, it has been repurposed for epilepsy treatment and has shown effectiveness in reducing seizures, particularly in Dravet syndrome. These alternatives offer different mechanisms of action and may provide additional options for patients who do not respond adequately to benzodiazepines.

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Benzodiazepine

Valtoco for Epilepsy

Phase 1 & 2

Waitlist Available

Research Sponsored by Neurelis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-6 hours

Awards & highlights

Study Summary

This trial is testing a new drug for epilepsy in young children. The drug will be given to a small group of children to see if it is safe and effective.

Who is the study for?

This trial is for children aged 2 to 5 with epilepsy who may need benzodiazepine treatment for seizure control. They should have had seizures that required rescue medication in the last three months or might need such intervention occasionally. Kids under 6 kg or over 33 kg, those in recent trials, surgeries, injuries, or with conditions affecting study results can't participate.Check my eligibility

What is being tested?

The study tests VALTOCO® (Diazepam Nasal Spray) to see how it's processed by young bodies and its safety as a single-dose treatment for seizures in pediatric patients. It's an early-stage trial (Phase 1/2a), meaning it's partly about checking the right dosages and initial responses.See study design

What are the potential side effects?

While not explicitly listed here, Diazepam nasal spray side effects could include drowsiness, headache, nasal discomfort, and potentially more serious effects like trouble breathing or severe dizziness which are common to benzodiazepines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-6 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-6 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age

Trial Design

1Treatment groups

Experimental Treatment

Group I: Valtoco In Pediatric Subjects with EpilepsyExperimental Treatment1 Intervention

5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.

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, such as benzodiazepines like diazepam, work by enhancing the effect of the inhibitory neurotransmitter GABA at the GABA-A receptor, leading to increased inhibitory effects in the central nervous system and reducing seizure activity. Other antiepileptic drugs (AEDs) include sodium channel blockers like carbamazepine and phenytoin, which stabilize neuronal membranes, and calcium channel blockers like ethosuximide, which reduce neurotransmitter release. Understanding these mechanisms is crucial for epilepsy patients as it helps tailor treatments to individual needs, optimizing seizure control and minimizing side effects.

Comparative study on the efficacy and safety of low-dose sodium valproate vs. diazepam in the prevention and treatment of pediatric febrile convulsion.

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Who is running the clinical trial?

Neurelis, Inc.Lead Sponsor

3 Previous Clinical Trials

256 Total Patients Enrolled

3 Trials studying Epilepsy

256 Patients Enrolled for Epilepsy

Media Library

Diazepam Nasal Spray [Valtoco] (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05076838 — Phase 1 & 2

Epilepsy Research Study Groups: Valtoco In Pediatric Subjects with Epilepsy

Epilepsy Clinical Trial 2023: Diazepam Nasal Spray [Valtoco] Highlights & Side Effects. Trial Name: NCT05076838 — Phase 1 & 2

Diazepam Nasal Spray [Valtoco] (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076838 — Phase 1 & 2

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